Careers

Careers Celegence - Life Science Regulations

At Celegence, you have the opportunity to shine and truly make a difference.

We have a growing organization where your inputs will be valued.

We have roles for all levels; both recent graduates and experienced professionals. We are currently looking for applicants with the following backgrounds

Celegence offers competitive compensation and benefits, growth opportunities, and a supportive work environment

Project Delivery Management - Celegence Life Science

Project Delivery Management

Regulatory Affairs Data Management

Compliance Data Management - Celegence Life Science

Compliance Data Management

Regulatory Intelligence

Current Job Openings at Celegence

Associate Director – Regulatory Services – India

Celegence is looking for an experienced Associate Director for Regulatory Services, Pharmaceuticals who can manage our fast-growing team in Bangalore, India.

Roles & Responsibilities

  • Expand and manage the growing 65+ services team to deliver various Regulatory Affairs related services for pharmaceutical clients
  • Involvement in worldwide practice development activities
  • Generate & manage work plan, key deliverables, resourcing plan, roles and responsibilities, risks, issues and dependencies
  • Plan and deploy support activities to ensure effective delivery
  • When required, participate in pre-sales activities to ensure they reflect realistic project delivery
  • Provide leadership, motivation and direction to the team
  • Monitor and report the progress against the Service Delivery Plan
  • Assure and improve the quality of services we are providing to our clients
  • Implement Operating and Delivery Model, Quality Control Plan and Customer Data Protection processes
  • Review above mentioned deliverables with management and implement respective process areas
  • Report progress on KPIs on a regular basis to the Celegence management team
  • Build delivery team by supporting interviews and ensuring on-boarding process includes training for all new resources
  • Responsible for managing delivery as per SLA in accordance with the SOWs
  • Collaborate with other departments like Product Engineering, Product Management, Business Unit, etc. to improve service offerings and overall customer satisfaction
  • Work with Quality Control team on different process areas related to service delivery
  • Support roadshows and industry events like DIA etc. to promote company’s solution and services
  • Implement and practice company core values
  • Responsible for Service Delivery KPIs and Financial Objectives for Delivery
  • Understand and abide by ISMS policy and processes of the company
  • Interact with customers and prospects to help promote regulatory services

Education & Experience

Education:

  • Bachelor’s Degree in Computer Science, Engineering or any relevant Life Sciences fields. Master’s Degree preferred.
  • PMP, RAC, ITIL certification is a plus.

Experience:

  • Minimum 15 years of relevant experience
  • Experience in the Life Sciences Industry and in Regulatory Affairs
  • Understanding of global regulations related Pharmaceutical and Biologics in the context of service offerings
  • Experience in managing Regulatory Affairs either as part services organization or life sciences company
  • Able to work independently
  • Fluent in English

Skills and Competencies

Technical Skills:

  • Project Management

Non-Technical Skills:

  • Good knowledge of strategy development and implementation techniques
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem-solving skills
  • Excellent Communication (writing and verbal)
  • Customer focused
  • Organization skills
  • Drive to deliver superior quality proposals and product
  • Strong time management
  • Good stakeholder management
  • Strong project management skills
  • Positive attitude
  • Initiative and commitment
  • Detailed oriented
  • Team player

Medical Device Regulatory Consultant – Europe, UK, USA

Roles & Responsibilities

  • Maintain, develop, and share your expertise and knowledge on a specific expert area and participate in MDR related forums to understand the latest trends as well as approach prospective clients
  • Actively participate in client bid defense meetings for Medical Device prospective projects
  • Provide advisory consulting services, proactively monitor regulations across regions to advise companies on new regulations
  • Provide SME consulting in the areas of regulatory strategy, submissions and operations
  • As a medical device expert, you will support to build (technical) documentation and design dossiers in support of CE marking, 510(k), or other approval procedures
  • Provide SME consulting for Regulatory compliance according to the current EU Directives (i.e. MDD & IVD), new EU Regulations MDR & IVDR (EU 2017/745 & EU 2017/746), FDA, ANVISA, Heath Canada, MHLW/PMDA & TGA (MDSAP requirements)
  • Lead MDR gap analysis projects and conduct analysis of existing systems, processes and departments in terms of new regulation.
  • For MDR Gap Assessments you will perform the following: Work with stakeholders to identify required changes to compliance processes and updating associated process documentation including Technical, Quality, Clinical, Post-Marketing, Labeling, Economic Operators and other areas
    • Implement improvements to technical files and other documents like Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER)
    • Understand current compliance situation of medical device to international standards
    • Suggest and support implementation of changes to organization’s risk management processes
    • Develop device risk assessments with input from clinical and technical experts within the organizations
    • Identify actions required to ensure compliance with ISO 13485, MDSAP and MDR
    • Supporting and conducting updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with EU-MDR
    • Make updates to labelling, SOPs, work instructions and policy documents to ensure compliance with the client’s corporate SOPs
  • Assist in the development/construction of Technical Files according to the new MDR & STED format with emphasis on developing following documentations:
    • Essential Requirements Evaluation Report to Annex I of MDR & IVDR
    • Risk Management Reports / Documentation to ISO 14971:2012
    • Clinical Evaluation Report development according to MDR & IVDR and/or MEDDEV 2.7.1 Rev 4
    • PMCF Planning Report development according to MDR & IVDR and/or MEDDEV
    • Development of Vigilance Reporting strategies to MDR & IVDR and/or MEDDEV
  • Support regulatory submission projects with submission requirements for appropriate market and product type
  • Establish and maintain a professional and credible relationship with direct clients (customer of Celegence) and indirect clients like Health Authorities, Notified Bodies and other regulatory agencies
  • Responsible for the operational planning of the project and prepares weekly plans for the team which are in line with the project time lines
  • In collaboration with Quality Assurance, ensure that project team members are appropriately trained on all project SOPs, guidelines and documents as required
  • Proactively follow the news and trends in the market to share with the rest of the team
  • You may be asked to support marketing activities, such as webinars, blog writing, as well as business development activities such as presales meetings with prospective clients
  • Supporting internal and external audits as required
  • Provide status reporting to stakeholders according to an agreed communications plan

Education & Experience

Education:

  • Bachelor’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree is preferred
  • RAC certification: Medical Devices is a plus

Experience:

  • Minimal 5 years working experience in the field of medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA, EMA), in either manufacturing, R&D, quality or regulatory roles
  • Experience writing MDR compliant Clinical Evaluation Reports and other documents
  • Knowledge of Quality Management Systems implementation to ISO 13485:2016
  • Knowledge of Risk Management Systems based on ISO 14971:2012
  • Experience in creating customer facing materials and conducting workshops as SME
  • Knowledge of Medical Device Regulations related to major health authorities of US, EU, Japan, China, Australia, Brazil, Canada
  • Worked in a client-focused organization as a consultant in the past
  • Hands on experience in managing all regulatory affairs activities and ensuring full regulatory compliance for medical devices
  • Fluent in English

Skills and Competencies

Technical / Functional Skills:

  • Excellent knowledge of MDD/MDR
  • Excellent knowledge of ISO 13485 standards
  • Good understanding of IMDRF requirements for member countries
  • Strong stakeholder management experience

Non-Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Good knowledge of strategy development and implementation techniques for Medical Device registrations, compliance towards new regulations etc.
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management
  • Project management and tracking

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skills
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Medical Reviewer/Labeling – Regulatory Affairs

Roles & Responsibilities

  • MedDRA search strategy inclusive of knowledge on SMQ
  • Signal detection activities including preparation of evaluation report
  • Evaluation of PRAC report and provide justification for inclusion and exclusion
  • Review of gap analysis and provide medical justification comments for inclusion or exclusion of deviation
  • Review ADR and identify Preferred Terms (PT) for line listings
  • Review of line listings cases
  • Literature review
  • Health Authority website check for safety changes
  • Preparation of medical justification document
  • Provides general regulatory guidance
  • Coordinate with external teams for language translations and include translated information in the relevant documents
  • Ability to interpret and communicate scientific or medical information in a clear and concise manner
  • Provides general regulatory guidance
  • Mentoring less senior team members
  • Contributing as part of the Medical review team to develop processes, training plans/modules and SOPs
  • Perform other duties as assigned
  • Maintaining knowledge of the current regulations and upcoming changes
  • Review and inputs to aggregate reports and risk management plans (RMP)

Education & Experience

Education:

  • MBBS/ MD

Experience:

  • 4+ years of combined experience in pharmacovigilance (PV), clinical research, clinical data management and medical practice
  • Good knowledge of ICH GCP and other regulatory requirements that govern the Safety of Medicines in EU, US and the Emerging markets
  • Experienced in Aggregate Reporting (PSUR/PBRER), Literature Review and Signal Detection

Skills:

  • Strong understanding of the use of medical terminology
  • Fluent in written and verbal English
  • Proficient with computer skills, including MS Office applications

Competencies:

  • Knowledge of PV regulations
  • Ability to multitask under tight deadlines while providing attention to detail and high quality work in a dynamic environment
  • Scientific knowledge sufficient to understand all aspects of regulatory issues

Personal Traits:

  • Good planner
  • Well organised
  • Strong team player
  • Customer focused
  • Skilled communicator
  • Ability to work independently

Senior Medical Writer – India

Celegence is seeking a Senior Medical Writing Specialist to join our consulting team in support our expanding list of Medical Device clients. The medical writer will be responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the clients Strategic Medical Affairs Team for a wide range of audiences.

Roles & Responsibilities

  • Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas
  • Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs
  • Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation
  • Assist the Team Lead/Manager in the development of schedules to ensure timely delivery
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
  • Train and mentor junior members of the team on technical/process related aspects
  • Conduct proofreading, editing, document formatting, review comment incorporation and document completion / approval activities
  • Perform literature searches on various databases
  • Screening, appraisal per pre-defined criteria, and summarization of articles
  • Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use
  • Summarize quantitative data from post-marketing surveillance
  • Conduct editing, proofreading, document formatting, and other document completion/approval activities

Education & Experience

Education:

  • Bachelor’s Degree / Post Graduation in any relevant Life Sciences fields. Master’s Degree is preferred

Experience:

  • Publication experience in scientific journals preferable
  • Minimum 3 years of experience in Medical Device Regulatory documentation
  • Familiarity with the Life Sciences Industry, preferably Regulatory Services
  • Hands on experience on CEP/CER/PMSR/PSUR process
  • Experience in creating high quality deliverables for customers
  • Experience in handling projects and engaging with multiple clients independently
  • Experience of working on projects  involving all devices classes from various Therapeutic Areas

Skills and Competencies

Technical / Functional Skills:

  • Knowledge of clinical evaluation and related documents and regulatory requirements
  • Proficiency in comprehension of scientific data and medical terminology and efficiency in summarizing information from source documents and published literature
  • Proficiency with Microsoft Office (Word, Excel, and Outlook)
  • Hands on experience on presentation tools such as PowerPoint, Visio etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage
  • Effective reviewing skills for review of work done by trainees/junior writers

Non-Technical Skills:

  • Strong verbal and written communications skills
  • Ability to work as part of a team
  • A constant zeal towards learning and skill development
  • Potential to multitask and work within timelines
  • Ability to understand and deliver on customer requirements
  • Mentoring skills to act as trainer/mentor for junior members of the team

Competencies:

  • Basic English grammar, punctuation, and sentence construction
  • Logical comprehension
  • Knowledge of medical terminology
  • Excellent Communication (Writing and Verbal)
  • Quality focused mindset
  • Good time management
  • Good stakeholder management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Detail Oriented
  • Team player
  • Focused and sincere
  • Ownership and accountability of work

SME – Regulatory Information Management System – India

Celegence is looking for a Subject Matter Expert with dedicated business process for Regulatory Information Management and Standards to our cross-functional projects and strategic initiatives like IDMP as well as the implementation of RIMS application.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • Responsible for using and updating RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions
  • Manage various activities in RIMS database under product life cycle management (Registration, Variation, Renewals and submission)
  • Prioritize target activities and Produce high quality deliverables
  • Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key deliverables.
  • Adherence to appropriate regulatory guidelines, departmental SOPs and Client SOPs for the deliverables.
  • Complete trainings provided by Client, and regular self-trainings; archive training certificates/records.
  • Assist and support internal audits performed by Client
  • Support implementation of Regulatory Affairs systems as per Client or Partner projects
  • Support peers and resolve issues related to project
  • Develop and establish standard processes in collaboration with QA submission related checklists and template preparation (wherever applicable)
  • Conduct quality control of performed regulatory work as part of the daily routine
  • Set-up and maintain local SOP system describing all procedures and processes in order to ensure compliance and share with Client
  • Effective usage of applicable RA electronic systems
  • Accountable for resource utilization, management and competency development of the teams assigned with inclusion at Individual level role
  • Understands and will abide by IQMS policy and processes of the company
  • Working knowledge of learning management systems

Education

  • Bachelor’s Degree in pharmacy or any relevant Life Sciences fields. Master’s Degree is preferred
  • RAC certification is a plus

Experience

  • Minimum 7 years of relevant Regulatory Affairs experience required
  • Experience with xEVMPD and IDMP will be preferred, including process definition and optimization for RIMS
  • Skilled in Regulatory Information Management
  • Business processes experience and good understanding of RIMS processes, Publishing, Labeling, CMC and Other Variations, Manufacturing and supply chain etc.
  • Performed SME role in the past for implementation projects and regulatory affairs related business process areas and training delivery experience is a plus
  • Hands on experience at developing eLearning courses with SCORM/AICC Compatible for LMS along with Instruction Design
  • Design and develop training courses and programs necessary to meet training needs, or manage this activity via internal /external providers
  • Member of Center of Excellence team responsible lifecycle management of assigned tasks in RIMS
  • Understanding of global regulations related Pharmaceutical, Medical Device, Biologics in the context of service offerings
  • Working experience or understanding of external pharmaceutical data standards like pharmacopeia, standard terms, ISO, MedDRA, EDQM etc.
  • Knowledge of regulations, legislation, best practices and guidelines relating to RIMS or compliance initiatives. (i.e. GxP, Annex 11, 21 CFR Part 11, ISO standards etc.)
  • Experience in customer interaction
  • Able to work independently
  • Fluent in English

Technical Skills

  • Hands on experience related to Regulatory Processes including related IT systems
  • Hands of experience on presentation tools like PowerPoint, Visio etc.

Non Technical Skills

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Worked in the capacity of lead or senior role responsible for project or sub workstream in the past

Competencies

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Drive to deliver superior quality proposals
  • Strong Time management
  • Good Stakeholder management

Personal Traits

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skill
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perserverance

Senior React JS Developer – India

Celegence is looking for an Senior React JS expert with skills to transform static website designs into rich, interactive, multimedia web experiences.

Roles & Responsibilities

  • Developing new user-facing features using React & Redux.
  • Building reusable components and front-end libraries for future use
  • Translating designs and wireframes into high quality performant code
  • Optimizing components for maximum performance across a vast array of web-capable devices and browsers
  • Work on creating tools to improve CX/DX
  • Mentor other UI developers
  • Take Ownership of work
  • Be Accountable

Education & Experience

Education:

  • Any Degree

Experience:

  • Strong proficiency in JavaScript, including DOM manipulation and the JavaScript object model
  • Thorough understanding of React.js and its core principles
  • Experience with popular React.js libraries (such as Redux, formik, jest etc.)
  • A knack for benchmarking and optimization.
  • Familiarity with newer specifications of EcmaScript
  • Experience with data structure libraries (e.g., Immutable.js)
  • Knowledge of isomorphic React is a plus
  • Familiarity with RESTful APIs
  • Knowledge of modern authorization mechanisms, such as JSON Web Token
  • Familiarity with modern front-end build pipelines and tools
  • Experience with common front-end development tools such as Babel, Webpack, NPM, etc.
  • Ability to understand business requirements and translate them into technical requirements
  • Familiarity with code versioning tools like git/gitlab

Skills and Competencies

Competencies:

  • Good Communication Skills (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Work hours: 10 AM – 7 PM on weekdays

Full Stack Developer – NodesJS + React JS – India

Celegence is looking for a full stack developer with 5 – 14 years of web application software development experience, having a focus on both front-end & back-end development.

Roles & Responsibilities

  • Take ownership and accountability of specific modules within an application and provides technical support and guidance during solution design for new requirements, problem resolution for critical/complex issues
  • Ensure code is maintainable, scalable and supportable
  • Investigate issues by reviewing/debugging code and providing fixes (analyzes and fixes bugs) and workarounds, will review changes for operability to maintain existing software solutions, will highlight risks and will help mitigate risks from technical aspects
  • Bring continuous improvements/efficiencies to the software or business processes by utilizing software engineering tools and various innovative techniques and reusing existing solutions. By means of automation, reduces design complexity, reduces time to response, and simplifies the client/end-user experience

Education & Experience

  • Bachelor’s degree in Science/IT/Computing or equivalent
  • Total experience: 5 – 14 years

Frontend Experience:

  • Expert knowledge of React/Redux + Hooks, Thunk, Javascript ES6, HTML5, CSS3 (must)
  • Knowledge in ant design (optional)
  • Knowledge in CSS extension frameworks e. g. SASS, LESS
  • Good knowledge in Object Oriented Design and development
  • Solid web apps design, coding, testing and debugging skills

Backend Experience:

  • NodeJS with API and microservices concept
  • Express JS
  • Bootstrap 3/4
  • Knowledge in MySQL, MongoDB
  • Knowledge of AWS, Redis , ElasticSearch, Box storage

Skills and Competencies

Technical Skills:

  • Project Management
  • Strong understanding of Software Development Life Cycle (SDLC) management

Non Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Able to work independently
  • Fluent in English

Competencies:

  • Good Communication (Writing and Verbal)
  • Customer Focused
  • Strong Time management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Strong comprehension, analytical and problem solving skills
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Application Front End Developer – India

Celegence is looking for an Application Front End Development expert with skills to transform static website designs into rich, interactive, multimedia web experiences.

Roles & Responsibilities

  • Use ReactJs and Redux to create user-friendly web page application
  • Convert application designs into web pages
  • Develop, Maintain and improve website
  • Optimize applications for maximum speed
  • Design and implement responsive features
  • Collaborate with back-end developers and web designers to improve usability
  • Get feedback from, and build solutions for, users and customers
  • Create quality mockups and prototypes
  • Help back-end developers with coding and troubleshooting
  • Ensure high quality graphic standards and brand consistency
  • Stay up to date on emerging technologies
  • Support Front End development and bug fixes

Education & Experience

Education:

  • Any Degree

Experience:

  • Experience in B2B product development environment
  • Minimum 7+ years of relevant experience
  • Minimum 4 + years in JavaScript + minimum 3 years in ReactJS.
  • Hands on experience with ReactJS, Redux, NodeJS, other Front end Javascript Libraries and Database concepts
  • Experience with JavaScript, CSS and jQuery
  • Experience with browser testing and debugging
  • In-depth understanding of the entire web development process (design, development and deployment)
  • Experience with Gitlab, Git, Visual Studio like tools
  • Understanding of layout aesthetics
  • Familiarity with software like Adobe Suite, Figma, Photoshop and content management systems
  • An ability to perform well in a fast-paced environment
  • Excellent analytical and multitasking skills

Skills and Competencies

Competencies:

  • Good Communication Skills (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Work hours: 10 AM – 7 PM on weekdays

Junior Associate – Regulatory Services – India

Celegence is looking for a Junior Associate – Regulatory Services who can join within 30 days & with minimum 3 years of relevant Regulatory Affairs experience.

Roles & Responsibilities

  • Responsible for using and updating RA systems like Regulatory Information Management system (RIMS) for Data enrichment, Quality Check, Local Updates, Master Updates
  • Manage various activities under product life cycle management (Registration, Variation, Renewals and submission)
  • Prioritize target activities and Produce high quality deliverables
  • Adherence to appropriate regulatory guidelines, departmental SOPs and Client SOPs for the deliverables
  • Complete trainings provided by Client, and regular self-trainings; archive training certificates/records
  • Assist and support internal audits performed by Client
  • Conduct peer QC of performed regulatory work as part of the daily routine
  • Accountable for resource utilization, management and competency development of the teams assigned with inclusion at Individual level role

Education & Experience

Education:

  • Bachelor’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree is preferred

Experience:

  • Minimum 3 years of relevant Regulatory Affairs experience required
  • Maintain knowledge and awareness of regulations and guidelines pertaining to drugs and biologics
  • Familiar with the Life Sciences Industry, preferably Regulatory
  • Skilled in Regulatory Information Management (RIMS), data entry, Data enrichment and Data collection from other sources
  • Experienced in Data management in REGISTER or related applications is preferred
  • A good understanding of the different modules and functionality of various RIMS tools
  • Understanding of global regulations related Pharmaceutical, Medical Device, Biologics in the context of service offerings
  • Working experience or understanding of external pharmaceutical data standards like pharmacopeia, standard terms, ISO, ICH, EDQM,MDM etc.
  • Good interpersonal, organizational, and time management skills
  • Ability to handle matters of strict confidentiality and sensitivity
  • Knowledge of regulations, legislation, best practices and guidelines relating to RIMS or compliance initiatives. (i.e. GxP, Annex 11, 21 CFR Part 11, ISO standards etc.)
  • Able to work independently
  • Fluent in English

Skills:

Technical Skills:

  • Hands on experience related to Regulatory Processes including related IT systems
  • Basic knowledge about MS Office: Outlook, Work, Excel, PowerPoint, etc.

Non-Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Worked in the capacity of lead or senior role responsible for project or sub workstream in the past

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Drive to deliver superior quality proposals

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Attention to Detail
  • Team player

Associate Manager – Publishing – India

Celegence is looking for a Publishing Associate Manager who will be responsible for new submissions and lifecycle management of assigned products for different countries.

Roles & Responsibilities

  • Member of Center of Excellence team responsible for new submissions and lifecycle management of assigned products for different countries
  • Prepare and perform quality review of all dossiers and documents written for Client submissions. Act as reviewer, based on project requirement
  • Compiles and verifies dossier in the required format of submission to the relevant agencies
  • Manage various activities under product life cycle management (Registration, Variation, Renewals and submission)
  • Prioritize target activities and Produce high quality deliverables
  • Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key deliverables
  • Adherence to appropriate regulatory guidelines, departmental SOPs and Client SOPs for the deliverables
  • Handling of the answer to queries from the health authorities
  • Complete trainings provided by Client, and regular self-trainings; archive training certificates/records
  • Assist and support internal audits performed by Client
  • Support implementation of Regulatory Affairs systems as per Client or Partner projects
  • Mentor and support peers and resolve issues related to project
  • Evaluate and allocate the workload of the team to maintain project timelines
  • Develop and establish standard processes in collaboration with QA submission related checklists and template preparation
  • Conduct quality control of performed regulatory work as part of the daily routine
  • Set-up and maintain local SOP system describing all procedures and processes in order to ensure compliance and share with Client
  • Effective usage of applicable RA electronic systems
  • Accountable for resource utilization, management and competency development of the teams assigned
  • Understands and will abide by ISMS policy and processes of the company
  • Prepare RCA and CAPA documents in coordination with QA

Education & Experience

Education:

  • Bachelor’s/Master’s Degree in pharmacy with relevant experience in Life Sciences fields
  • RAC certification is a plus

Experience:

  • Minimum 6 years of relevant Regulatory Affairs experience required
  • Sound Understanding of global regulations related to Pharmaceutical, Medical Device, Biologics in the context of registrations
  • Experienced with the use of publishing tools related to report and submission publishing
  • Familiar with ICH CTD, eCTD, SPL and other data standards
  • Familiar with eCTD standards followed by different countries like US, EU, JAPAN, China etc.
  • CRF and CSR bookmarking and hyperlinking
  • Must have excellent computer skills with an in-depth knowledge of:
  • MS Word for processing source documents to submission ready standards
  • Adobe Acrobat and ISI/TRS Toolkit for remediating PDFs to submission ready standards
  • MS Excel for planning and tracking purposes
  • Must have excellent organizational skills with proven ability to multi-task and prioritize projects
  • Must have a very high attention to detail
  • Good communication skills, both verbal and written
  • Must be a team player, yet can work independently within project teams
  • Prior experience with service industry preferred

Skills:

Technical Skills:

  • Expertise in Regulatory Processes and eCTD tools
  • Hands of experience on presentation tools like PowerPoint, Visio etc.
  • Preparation and presentation of team matrix

Non-Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Worked in the capacity of lead or senior role responsible for project or sub workstream in the past
  • Must be able to contribute in Team and Individual capacities
  • Ability to train and develop team members

Competencies:

  • Good Communication Skills (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Drive to deliver superior quality proposals
  • Strong Time management
  • Good Stakeholder management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skill
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

UI/UX and Web Designer / Developer – India

Celegence is looking for a UI/UX and web designing expert with skills to design and develop the front end of our software solution.

Roles & Responsibilities

  • Working with project teams to implement overall UX strategy, create Interaction models, design effective interactions through wireframes and prototypes
  • Performing Heuristic Evaluations and Usability Reviews
  • International and Diverse Culture exposure
  • Able to design in CSS, java script using frameworks like React and html
  • Proven UI experience
  • Demonstrable UI design skills with a strong portfolio
  • Expert in UI/UX Definition and Design stages.
  • Creating UI/UX Design concepts for rapid prototyping
  • Expert in designing UI/UX solutions for Web, Mobile and other hand-held business and consumer devices
  • Deliverables:
    • Personas, Contextual Inquiry and User Interview findings
    • Information Architecture, Task Flows, Wireframes, Heuristic Evaluation, Expert Reviews, Mock-ups
    • HTML designs, CSS and other technical deliverables to the application development team
    • Web application Front End Components using React and Redux
  • Coordinate with the Backend developers and implement the module
  • Support Front End development and bug fixes

Education & Experience

Education:

  • Any Degree

Experience:

  • 3-5 years related work experience in B2B product design/ development environment
  • Hands on Contextual Inquiry, Persona Creation, Information Architecture, UX Analysis, Interaction Design, Responsive UI/UX Design, Design for Devices
  • Paper/ rapid prototyping skills
  • Must have strong turnaround skills backed with sound understanding of any given design problem
  • Strong experience with CMS Product UI/UXdevelopment
  • Versatile experience in developing responsive designs for all devices like Desktops, Laptops, Tablets and Mobiles
  • Strong ability to convert the designs into Front End components using ReactJS
  • Strong hands on experience with ReactJS, Redux, Ant Designs
  • Ability to modify and customize Ant Design components to fit into the product design
  • Good experience with NodeJS
  • Strong communication and assertive skills
  • Experience with developing websites using WordPress

Skills and Competencies

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Senior Full Stack Developer – US/UK

Celegence is looking for a full stack developer in our US or UK location with 10 years of web application software development experience. This person should be able to manage a team of developers with hands-on experience in both front-end & back-end development.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • Develop applications using React/Node.js/MySQL with web sockets/AJAX
  • Help advise on the technology stack (end to end)
  • Work within a fast paced Agile/Scrum methodology
  • Use SOAP and REST to implement API integrations with other SaaS platforms
  • Experience in enterprise architecture, designing concepts, exposure to different design patterns for UI, Persistence and development of solution
  • Experience with Document Management Solutions like Box with good understanding of its APIs

Education & Experience

  • 6+ years of experience in Node.js, MySQL and AWS, 4+ years in React.js
  • js with Express, MySQL and MongoDB, Passport
  • Microservice Architecture understanding and hands-on implementation
  • Hands-on development experience building 3rd party applications using Box.com e.g. Content Management APIs, Custom APIs, User and Groups security and collaboration, Search, etc.
  • Strong proficiency in JavaScript, including DOM manipulation and the JavaScript object model
  • Experience with popular React.js workflows (such as Flux or Redux)
  • Familiarity with RESTful APIs
  • Knowledge of modern authorization mechanisms
  • Familiarity with modern front-end build pipelines and tools
  • Experience with common front-end development tools such as Babel, Webpack, NPM, etc.
  • Ability to understand business requirements and translate them into technical requirements
  • Working knowledge of containerization
  • Basic knowledge on Kubernetes
  • Knowledge on any NOSQL database Skills
  • Database Schema Design and development
  • Hands on skills with Database Stored Procedures, Views, Database Security

Skills and Competencies

  • Possess strong verbal and written communications skills
  • Ability to influence others & problem resolving skills
  • Ability to work independently
  • Should be a team player

Application Back End Developer – India

Celegence is looking for an Application Backend Development expert.

Roles & Responsibilities

  • Be involved and participate in the overall application lifecycle
  • Main focus to be on coding, unit testing and debugging
  • Collaborate with Front-end developers
  • Define and communicate technical and design requirements
  • Provide training, help and support to other team members
  • Build high-quality reusable code that can be used in the future
  • Develop functional and sustainable web applications with clean codes
  • Troubleshoot and debug applications
  • Experience with building API’s and Webservices
  • Experience with Micro-service architecture applications
  • Manage cutting-edge technologies to improve applications
  • Collaborate with multidisciplinary team of designers, developers and system administrators
  • Learn about new technologies
  • Stay up to date with current best practices
  • Conduct UI tests and optimize performance
  • Participate in conferences and educational programs
  • Follow new and emerging technologies

Education & Experience

Education:

  • Any Degree

Experience:

  • 3-5 years related work experience in B2B product development environment
  • Hands on experience with NodeJS, other Front end Javascript Libraries and MySQL Database
  • Experience with ORM libraries like Sequelize
  • Experience with browser testing and debugging
  • Experience with API testing tools like Postman etc.
  • In-depth understanding of the entire web development process (design, development and deployment)
  • Experience with Gitlab, Git, Visual Studio Code like tools
  • Familiarity with front-end languages such as HTML, JavaScript and CSS
  • Critical thinker and problem-solving skills
  • An ability to perform well in a fast-paced environment
  • Excellent analytical and multitasking skills

Skills and Competencies

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Medical Devices Registration Manager – India

Celegence is looking for a Medical Device expert to oversee and deliver a project to support our client with registering multiple medical device products in several countries.

Roles & Responsibilities

  • Familiarize with pharmaceutical and medical device products related regulations, requirements and guidelines. Also, be responsible for the implementation and compliance of the regulatory requirements
  • Manage product registration in line with company strategy to ensure compliance with local regulatory requirement and company requirements
  • Ensuring ongoing compliance and maintenance of product registration to meet regulatory and business obligations
  • Work closely with local regulatory authorities to ensure a high level of current knowledge is maintained regarding product registration and maintenance of product within the market segments the business aims to conduct its business
  • Ensuring promotion materials and communication to HCPs, customers and end users are reviewed in line with the company and industrial Codes of Conduct. Apply advertisement permit when required
  • Manage the reporting and management of Pharmacovigilance activities for Medical Devices in India, Sri Lanka and Bangladesh in accordance with the company SOPs and local regulatory requirements
  • Support local quality activities by working closely with cross functions and external organization like:
    • Local Commercial, Supply Chain team
    • Global RA, Packaging Group, Global Quality
    • Regional RA and Country RA teams
    • Consultants and Distributors
    • Government Agencies, Medical/Regulatory Authorities
  • Review and approve pharmaceutical product labels or artworks for production
  • Review and approve repack and relabel instruction for pharmaceutical products
  • Provide consultations to resolve the problems or incidences due to the regulations change
  • Understands and will abide by ISMS policy and processes of the company

Education & Experience

Education:

  • Bachelor’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree is preferred
  • RAC certification is a plus

Experience:

  • 5 years related work experience in Pharmaceutical and Medical Device Field
  • Familiar with the Life Sciences Industry, preferably Regulatory
  • Hands on experience in managing all regulatory affairs activities and ensuring full regulatory compliance for medical devices in India, Sri Lanka and Bangladesh is a must
  • Understanding of global regulations related Pharmaceutical, Medical Device, Biologics in the context of service offerings
  • Fluent in English

Skills and Competencies

Technical / Functional Skills:

  • Must be able to interact with internal Client teams and manufacturing site personnel in a professional manner
  • Work experience with Western Multi-National Companies in Pharmaceutical/Medical Devices fields
  • Must be familiar with Regulatory environment, and have an understanding of labeling regulations and controls
  • Strong project management and organizational skills
  • Individual must be flexible and capable of prioritizing projects, meeting deadlines, and working well under pressure

Non-Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Hands on person with a flair for Strategy formulation
  • Good knowledge of strategy development and implementation Techniques
  • Be a People Person & be able to weave into the Organization seamlessly
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management
  • Project management and tracking

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skill
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Regulatory Intelligence Subject Matter Expert – India

Celegence is looking for a Regulatory Intelligence SME to support both Regulatory Services and Technology Development for Regulatory Intelligence in Bangalore, India.

Roles & Responsibilities

  • Provide Regulatory Intelligence (RI) services, proactively monitor regulations across regions to advise companies on how to create successful submissions
  • Consult in the areas of regulatory strategy, submissions and operations
  • Act as a Regulatory Technology Product SME to guide strategy for Regulatory Intelligence platform development
  • Market research on competitor technologies related to Regulatory Intelligence capturing, storing and sharing
  • Review and conduct both primary and secondary research on global Regulatory requirements for specific product types for reports and input into technology platform
  • Support regulatory submission projects with submission requirements for appropriate market and product type
  • Collect regulatory requirements for eCTD submissions, labeling, pharmacovigilance, publishing and change management (variations)
  • Establish process and ensure adherence to the process related to RI information collection, review, quality checks, publish summary reports and engage consulting for client specific projects
  • Ensures appropriate and adequate resource allocation and back-up roles for project continuity timely delivery
  • Quality delivery through a rigorous metrics-based approach
  • Ensure timelines are being met
  • Complete trainings provided by Client, and regular self-trainings; archive training certificates/records
  • Review deliverables on a regular basis and ensure proper project execution and minimizes risk on project and products
  • Responsible for the operational planning of the project and prepares weekly plans for the team which are in line with the project time lines
  • In collaboration with Quality Assurance, ensure that project team members are appropriately trained on all project SOPs, guidelines and documents as required.
  • Ensures appropriate and adequate resource allocation and back-up roles for project continuity timely delivery.
  • Assist and support internal audits performed by Client.
  • Set-up and maintain local SOP system describing all procedures and processes in order to ensure compliance and share with Client
  • Conduct quality control of performed regulatory work as part of the daily routine
  • On need basis work with Subject Matter Experts (SME) from global network for country specific submission related topics
  • Accountable for resource utilization, management, competency development and other KPI established for services unit as well as teams assigned
  • Support pre-sales and marketing initiatives to promote RI Solution
  • Understands and will abide by ISMS policy and processes of the company

Education & Experience

Education:

  • Bachelor Degree in Pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree is preferred.
  • RAC certification is a plus.
  • PMP or ITIL certification is a plus.

Experience:

  • Minimum 5-7 years of relevant experience
  • Experience in Regulatory Affairs, specifically in gathering or monitoring regulatory intelligence across countries and regions
  • Understanding of global regulations related to Pharmaceuticals, Medical Devices and Biologics
  • Experience in creating customer facing materials
  • Able to work independently and manage a team if required
  • Fluent in English

Skills and Competencies

Technical Skills:

  • Project Management

Non Technical Skills:

  • Good knowledge of strategy development and implementation techniques
  • Excellent Communication and Writing Skills
  • Customer Focused
  • Customer Focused
  • Drive to deliver high quality proposals to clients
  • Good Stakeholder management
  • Strong Project management and tracking
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Medical Device Medical Writer (CER Specialist) – India

Celegence is seeking a Medical Writing Specialist to join our consulting team in support our expanding list of Medical Device clients. The consultant will be responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the clients Strategic Medical Affairs Team for a wide range of audiences.

Roles & Responsibilities

  • Ensure on-time development and delivery of high-quality CERs compliant with MEDDEV 2.7/1 Rev. 4. And EU MDR for devices across therapeutic areas
  • Be adept at delivering solutions that are customized per the client requirements
  • Assist in the development of schedules to ensure client CER timelines are met
  • Perform literature searches, screen and summarize literature for relevant clinical evidence
  • Study device-specific client documents and report device characteristics and instructions for use
  • Summarize data from post-marketing surveillance and perform risk analysis for the devices in scope
  • Actively engage with cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER process
  • Work with the team and Team Lead to prepare documents that meet client expectations in terms of content, format, and presentation
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
  • Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.

Education & Experience

Education:

  • Bachelor’s Degree / Post Graduation in any relevant Life Sciences fields. Master’s Degree is preferred.
  • RAC certification is a plus

Experience:

  • Minimum 2 years of relevant CER experience required
  • Familiar with the Life Sciences Industry, preferably Regulatory Services
  • Hands on experience on CER to perform their job role.
  • Experience in creating customer facing materials
  • Ability to work independently
  • Fluent in English

Skills and Competencies

Technical / Functional Skills:

  • Experience within the medical device industry and knowledge of clinical evaluation report, regulatory requirements, evidence generation, and CER document creation
  • Experience in Literature Search, Review and Analysis, Risk Benefit Assessment, Equivalency Approach, Post Market Surveillance Data Analysis including Trend CER – Analysis, Non-Clinical/Clinical Data (pre-clinical, Sponsored studies/IIR), State of the Art (SotA) and Conclusions.
  • Experience in performing medical literature searches (PubMed, Google Scholar, etc.)
  • Hands on experience on presentation tools like PowerPoint, Visio etc. will be an added advantage.

Non-Technical Skills:

  • Possess strong verbal and written communications skills, interpersonal skills, strategic thinking, ability to influence others & problem resolving skills
  • Client focused approach to work
  • Ability to prioritize and manage multiple projects

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Drive to deliver superior quality proposals
  • Strong Time management
  • Good Stakeholder management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Technical Architect – India

Celegence is looking for a technical architect to support our Regulatory Affairs platform development strategy in Bangalore, India.

Roles & Responsibilities

  • Work with application development teams, understand the functional requirements of the end applications and arrive at the functionality requirement for the platform
  • Stay updated on the latest trends/ technologies for cloud enablement and PaaS and evaluate the platform capabilities vis-à-vis the trends; plan the road map to incorporate the required functionality
  • Will be involved in research, architecture, design, development, testing, benchmarking and coordination with associated group(s)
  • Responsible for right design and development of multi-tiered, distributed architecture, scalable applications in a client-server / web environment
  • Provides knowledge leadership in relevant research areas, technology tools & standards and architectural governance. Provides guidance to project teams regarding guiding principles, system and application design, coding and design standards, best practices, and system performance and availability.
  • Technical assessment (e.g. platforms, tool proliferation, age of underlying technologies, uptime/availability, business processes)
  • Drive the technical strategy and lead team(s) in meeting the strategic objectives. Foster high performing technical teams. Identify and recruit technical leaders into the organization
  • Designs complex systems at the component level, makes strategic technology choices, and directly supervises the quality of designs and implementation inside and between components
  • Support and create a standard Framework for development projects, Common Library of re-usable components.
  • Directives and Framework to consistently write, translate, and code software programs and applications according to specifications.
  • Design, run and monitor software performance tests on new and existing programs for the purposes of correcting errors, isolating areas for improvement, and general debugging.
  • Participate in critical analysis of test results and deliver solutions to problem areas. the deliverable.
  • Complete training provided by Client, and regular self-training; archive training certificates/records.
  • Assist and support internal audits performed by Client.
  • Support implementation of Regulatory Affairs systems as per Client or Partner projects.
  • Understands and will abide by ISMS policy and processes of the company.

Education & Experience

Education:

  • Bachelor Degree in Engineering
  • Masters preferred
  • Relevant certification like TOGAF is a plus

Experience:

  • 12-15 years of software development experience using traditional software development life cycle methodologies (covering requirements, design, development, testing and Implementation of n-tier architecture)
  • Familiar with the Life Sciences Industry, preferably Regulatory
  • Extensive experience with object-oriented software development methodologies and practices. Strong in following technologies
    1. OOAD/OOPS/UML, Design Patterns, MVC, Struts, Spring, Hibernate, Java, .NET / J2EE
    2. Exposure to JSP, JSF, java script library, Ajax and UI frameworks
    3. Exposure to component model design, SOA, open sources framework/tools
    4. Web Services, JMS, XML, SQL& Oracle
  • Experience in developing platforms or frameworks, messaging frameworks, Enterprise application integration frameworks
  • Experience in building cloud enabled applications/ platform would be an asset
  • Experience in developing against API for cross functional requirements. (VMWare, EMC, Azure, AWS, Box)
  • Familiar with Enterprise Application Architecture and Design for Content Management and Collaboration solution would be an asset

Skills and Competencies

Technical Skills:

  • Must have exposed with Test Driven Development/Re-factoring ideas/ Domain driven design patterns/continuous integration/Build Automation / Data-Mapper framework/Mocks.
  • Background in implementing n-tier, Service Oriented Architecture (SOA) and MVP/MVC architecture. Product conceptualization to realization.
  • Must have Architected and Designed at least one Enterprise Class Application End to End
  • Well versed with tools for: Refactoring, Unit Testing, Design, Data Modelling, Profiling, Benchmarking
  • Excellent knowledge of the open source software/ tools/ technologies

Non Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Able to work independently
  • Fluent in English

Competencies:

  • Good Communication (Writing and Verbal)
  • Customer Focused
  • Strong Time management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Strong comprehension, analytical and problem solving skills
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance
Life Science Regulations - Celegence - Careers

Competitive Compensation & Benefits

Life Science Regulations - Celegence Growth Company

Supportive Work Environment

Life Science Regulations - Celegence Careers

Growth Opportunities

Join Our Team

​If you are interested in joining our team, please fill out the form below or email careers@celegence.com and we will contact you for further discussion.

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