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

Training Manager and RIMS Subject Matter Expert (Regulatory Services) – Global

Roles & Responsibilities

  • Own the training project charter and manages the day-to-day activities of the training project plan
  • Report project progress, issues, and risks to the PMO
  • Manage logistics like preparing training rooms, prints materials and manage technical facility and coordination
  • Drive all phases of training workstream – Design, Content Development, Testing, Deployment and Support to Train The Trainers during “go live” as well as post “go live” hyper care period
  • Support users during hyper-care immediately after “go live”
  • Manage various stakeholders (Training Partner, Technology Provider, and end Client)
  • Ensure appropriate and adequate resource allocation and back-up roles for project continuity timely delivery
  • Ensure quality delivery through a rigorous metrics-based approach
  • Ensure timelines are always met
  • 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 timelines
  • In collaboration with Quality Assurance, ensure that project team members are appropriately trained on all project SOPs, guidelines and documents as required
  • Complete trainings provided by Client, and regular self-trainings; archive training certificates/records
  • Ensure 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
  • Manage resource utilization, management, competency development and other KPI established for services unit as well as teams assigned
  • Understand and abide by ISMS policy and processes of the company

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 RIMS (Regulatory Information Management Systems)
  • Experience in creating customer facing materials
  • Able to work independently and manage a team if required
  • Fluent in English

Technical Skills

  • Project Management
  • Hands-on experience for end-to-end Regulatory Operations for Mid/Large-sized Life Sciences companies
  • Skilled in Regulatory Information Management, including ArisGlobal LifeSphere RIMS
  • Experience with xEVMPD and IDMP, including process definition and optimization for RIMS
  • SOP and Work Instructions for ArisGlobal Register and LifeSphere RIMS
  • Experience in multiple areas of learning, including content design and development, performance improvement, measurement and evaluation, learning management systems, and emerging learning technology
  • Experience with multiple authoring tools including Adobe Captivate, Articulate Storyline, Trivantis Lectora, and others; Knowledgeable about various learning technology platforms, including LMS (Saba, Cornerstone, SumTotal, SuccessFactors), learning experience (Degreed, EdCast), learning hub/MOOC (Intrepid, Conduent Knowledge Connection), and others

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 resolving skills

Competencies

  • Excellent Communication and Writing Skills
  • Customer Focused
  • Organization Skills
  • Drive to deliver high quality proposals to clients
  • Good Stakeholder management
  • Strong Project management and tracking

Personal Traits

  • Positive Attitude
  • Leadership Skill
  • Initiative and Commitment
  • Detailed Oriented
  • Team Player

SME – Regulatory Information Management System – Global

Celegence is looking for a Subject Matter Expert with at least 8 years of experience in Regulatory Information Management Systems (RIMS) business processes and standards.

Roles & Responsibilities

  • Responsible for providing SME consulting related to RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions
  • Lead training content development for RIMS solution overing various business process areas like Product portfolio management, Registration / License management, Change management, Compliance data management, CMC and Labeling related processes, Dossier management, Publishing and Submission management, business processes relate system integrations
  • Lead demo and business process walkthrough sessions to the end-users as well as super users of RIMS
  • Manage various activities in the RIMS database under product life cycle management (Registration, Variation, Renewals, and submission)
  • Define and ensure KPIs and SLAs related to regulatory business processes and 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 the Client
  • Support implementation of Regulatory Affairs systems as per Client or Partner projects
  • Support peers and resolve issues related to the 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
  • Understands and will abide by the 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 8 years of relevant Regulatory Affairs experience required
  • Hands-on experience for end-to-end Regulatory Operations for Mid/Large-sized Life Sciences companies
  • Experience with xEVMPD and IDMP will be preferred, including process definition and optimization for RIMS
  • Skilled in Regulatory Information Management
  • Business processes experience and a 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 to 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
  • Understanding of global regulations related to Pharmaceuticals, Medical Devices, 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 in managing Regulatory Processes, including related IT systems.
  • Hands-on experience in using 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

Product Manager – India

Celegence is looking for a product manager in our Bangalore location with 10 years of business analysis and product management experience. This person should be able to coordinate between the client (business) team, developers, and testing team.

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.

About the Role

The Product Manager will be responsible for defining and prioritizing the work for our development team to ensure the most valuable and proper functionality of the product for the end client (the internal business team). He or she will ensure the product meets our company’s goals of increased efficiency, quality, and compliance for our internal business team comprised of medical writers. Excellent communication, organizational, and analytical skills are a must.

As the Product Manager, you will gather feature requests, schedule releases and coordinate sprints. You should be able to identify user needs, help the customer understand business value and work with cross-functional teams to manage product releases. You will ensure that the product is made as efficiently as possible and listen to the users of the product, finding out what new features they want before gathering and analysing their feedback. This helps the overall team make decisions about the future of the product – what will and won’t be possible, which features to prioritise or to drop altogether and produce product roadmaps. You will also be responsible for the life cycle of the product, ensuring that everyone is following the product roadmap and that features are being released on time and are of a high quality.

In your role, you may focus mostly on the users of your product, sometimes referred to as product marketing, or on the creation of the product itself, known as product development. Your effort is important for the company as you will need to deliver product not just according to users, but the product that helps make our company vision a reality.

Roles & Responsibilities

  • Serve as the voice of the client
  • Work with internal and external customers to analyze the needs and align product roadmap to strategic goals
  • Owns the product roadmap
  • Develop scope and define backlog items (epic/features/user stories) that guide the Agile software development team
  • Solve product related problems, make decisions, complete trade-off analysis to stay on track towards business deliverable commitments
  • Draft key objectives and results, strategies and apply the data for the product to make business decisions
  • Possess a fundamental understanding of end-to-end customer experience integration and dependencies
  • Collaborate with stakeholders during the visioning and concept development of a product
  • Accountable for the created product(s), delivering in the product model and communicating the product needs with business partners
  • Assess value, develop cases, and prioritize stories, epics, and themes to ensure work focuses on those with a maximum value that are aligned with product strategy
  • Identifies and help the client understand the business model, value, and value proposition
  • Develop and maintain an appropriately prioritized backlog of user stories for implementation
  • Act as an ambassador for the product internally and externally and as the primary contact for queries related to the product
  • Develop appropriately detailed specifications for the product features so they are clearly understood by the development teams
  • A leader of the team
  • Represents team in front of stakeholders, clients, or users
  • A member of the team
  • Work closely with product management and senior management in order to create a product that fits the company portfolio
  • Research and analyze market, the users, and the roadmap for the product
  • Follow our competitors and the industry
  • Increase an understanding of Agile practices, Lean Start-up, new technologies opportunities and other new trends

Experience

  • Entrepreneurship skills or experience
  • Creative thinker
  • Strategic thinking
  • Product Management
  • Experience in sales or marketing is an advantage
  • Management of stakeholders and their expectation
  • Deep understanding and experience with Agile methodologies
  • Ability to work with cross-functional teams to deliver on a common goal
  • Interpersonal skills and developing relationships with team members and customers
  • Experience with a definition of minimum marketable features and minimum viable products
  • Knows how to define the product roadmap
  • Outstanding communication, presentation, and leadership skills
  • Organizational and time management skills
  • Analytical and problem-solving skills
  • Attention to details
  • Discipline
  • Active listening
  • Overall understanding of technologies used in the product

Commercial Director – US

Celegence is hiring a Commercial Director immediately to work for our US office. This individual will be responsible for leading the organization through the commercial landscape and ensuring a consistent trajectory of growth.

Summary

Celegence provides clients with solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing a team of experts who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations.

Celegence’s vision is to be the premier niche provider of Regulatory Affairs services to improve outcomes for our customers in 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. At Celegence, we take immense pride in what we do and how we do it. The successful candidates will strongly align with the organization’s mission and high standards.

Celegence seeks an ambitious, self-motivated, and analytical Commercial Director who is knowledgeable about the life sciences landscape, specifically regulatory affairs. The Commercial Director will be responsible for scaling Celegence’s growth and marketing initiatives, setting priorities, and ensuring all processes are trending up over time. Candidates must be willing to work in a fast-paced, growth-stage environment and thrive in a role that requires strategic thinking and creative problem-solving.

Roles & Responsibilities

  • Work with key stakeholders across the company to set and execute the strategy and roadmap for Celegence’s long term growth
  • Negotiate ongoing contracts with suppliers and customers
  • Review contracts and make recommendations on commerciality
  • Interpret market trends and adapt to industry changes
  • Streamline lead generation processes enabling sales teams to chase leads swiftly
  • Analyze opportunities for growth via acquisition and performing due diligence
  • Implement new sales strategies and ensuring departments follow industry best practice
  • Make commercial recommendations to the board of directors
  • Set and deliver company plan alongside other directors
  • Provide leadership for all Celegence business development opportunities
  • Manage a business development pipeline through effective use of metrics and tracking, while effectively communicating internal priorities, challenges, and opportunities that impact revenue growth
  • Develop collaborative working relationships with functional peers in the organization in pursuit of the company’s overall business goals
  • Leverage cross-functional resources, the company’s regulatory and technical expertise into deal discussion with new and existing clients
  • Create a repeatable sales process that can be replicated as the team grows
  • Over time, identify, select, and manage a strategic portfolio of channel partnerships that drive market share through seamless execution, partner amplification, and integrated product and service differentiation
  • Provide the “voice of the market” input and feedback to product and service management and influence marketing strategies effectively
  • Investigate and interact with potential and existing customers to drive knowledge and interest in our services and technology – position pilots for new technology across the industry to gain traction with new clients
  • Maintain a thorough understanding of the industry, including industry trends, best practices, business processes, industry financial measurements, performance indicators, and key competitors
  • Work with the management team on researching target opportunities and writing business proposals for both services and technology
  • Develop and manage existing client relationships – grow and expand these relationships based on revenue targets for each account
  • Manage any leads coming from the management team and website
  • Participate in Sales & Marketing meetings, attend networking events, industry trade shows, and various types of marketing activities to meet our growth and revenue objectives
  • Provide thought leadership, strategic insight, and clear communication (written and verbal) to the team on strategy, tactics, and metrics
  • Responsible for diverse activities such as website management, social media management, liaising with marketing agencies, overseeing marketing campaigns, designing promotional materials, inputs for SEO, etc.
  • Build a strong marketing and pre-sales team in the future to support and sustain the company’s growth

Qualifications

  • To qualify for a position as a commercial director, applicants must demonstrate exemplary project management, negotiation, market research, and typically marketing skills. Because the role is a prominent leadership position, organizations often demand between 5-10+ years of experience working in upper management for consideration
  • Experience in high-pressure roles where deadlines and bottom lines are the measure of success and heavy burdens of responsibility are the norm
  • Experience in consultative and value selling methodology, with a deep understanding of the client’s needs and Celegence’s capabilities
  • 5+ years minimum experience in life sciences business development
  • Successful track record of closing deals and partnerships
  • 3+ years working with SaaS, mobile application, cloud, and life sciences related industries is a plus
  • Experience selling to medical device and pharmaceutical companies preferred
  • Demonstration of analytical rigor with the ability to quantitively analyze and optimize marketing programs and growth initiatives

Preferred Skills

  • Strong interpersonal skills, an ability to eloquently convey complex ideas, and a good instinct for business
  • Comfort with technology and ease of personal interaction
  • Excellent organizational & multi-tasking skills
  • Strong verbal and written communication skills
  • Self-motivated, goal-oriented, inspire confidence, and a natural leader
  • Have had previous P&L experience
  • Good communication, budgeting, negotiation, people management, and social media skills
  • Experience with business process optimization and/or gathering business requirements
  • Exposure to Microsoft suite of products including Excel, Word, Access, and PowerPoint

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

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

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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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