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

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 5 – 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.)

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
  • Experience in customer interaction
  • Able to work independently
  • Fluent in English

Personal Traits

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

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

Full Stack Developer – JavaScript – India

Celegence is looking for a full stack developer with 3 – 4 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: 3 to 4 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
  • 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

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

Junior Quality Tester – India

Celegence is looking for a junior quality tester with 2 years of web application software testing experience.

Roles & Responsibilities

As the junior Tester, the responsibilities are as follows, but not limited;

  • Review requirements, specifications, user documentation, help files, and other project documentation to develop test script
  • Interact with management, Business analysis team and development teams to develop a strong understanding of the project and testing objectives
  • Use existing tools and techniques to execute test cases and build/script new tools for performing testing/validation function
  • Participate in troubleshooting and triaging of issues with different teams to drive towards root cause identification and resolution
  • Document, track and escalate issues as appropriate, using Quality Centre or similar tools/means
  • Support production deployment of applications and perform “validation testing”
  • Interact with business analysis and development teams on a regular basis to obtain requirement and design details.
  • Perform ad-hoc testing to support in researching issues
  • Perform other testing-related duties as required
  • Research and document bug reports following agreed-upon processes immediately upon discovery of a quality problem.
  • Experience developing and establishing testing criteria
  • Develop, Execute and analysis automation test results
  • Provide regular progress reports, status and metrics to management

Education & Experience

Overall the position requires familiarity with a variety of the field’s concepts, practices, and procedures. It also relies on extensive experience and judgment to plan and accomplish goals. The position requires at least 1-2 years of experience in the field or in a related area. The candidate should have good communication, be detailed oriented and quick to learn.

Required Skills:

  • Experience with end-to-end product and application testing
  • Experienced with various JavaScript testing frameworks like selenium testing framework
  • Experienced with Testing System API’s using tools like Postman
  • Experienced in Performance and Load testing tools
  • Experience with Linux Environment
  • SQL/PL/SQL – ability to develop medium to complex queries in MySQL

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

Business Analyst / Functional Tester – India

Celegence is looking for a Business Analyst who will work with business unit subject matter experts and managers to define/document requirements, align priorities and ensure development and integration needs are aligned across all departments including software development.

Roles & Responsibilities

  • Analyse business requirements by collaborating with business groups to identify, document, and communicate business needs and provide IT solutions
  • Perform current state analysis of existing business systems, applications, and functions
  • Document, analyse, and assess current business processes and underlying systems/applications
  • Plan, elicit, capture, analyse, and validate business, functional, and technical requirements
  • Coordinate functional and user acceptance testing by executing the testing strategy, scheduling resources, and tracking test performance
  • Perform data analysis to support evaluation of system defects or to develop requirements for new functionality; triage and troubleshoot complex user-reported system defects; assist in various system troubleshooting and balancing/correcting efforts including analysis, verification, and validation of issues/fixes
  • Assist in the development of data models and interface design specifications
  • Assist in systems and business process support across multiple client engagements
  • Work as a technical support and liaison to designated IT personnel to provide testing, support, and feedback on enhancement requests and regular updates/releases; adhere to release schedules
  • Demonstrate a high level of subject matter expertise in functional area to bridge business requirements and IT solutions; provide technical direction and ensure compliance with optimum practice solutions
  • Practice knowledge transfer and foster change management as the organization changes and new skills are required, focusing on team/individual development; perform other assigned duties.
  • Documentation of requirements using tools like GitLab, Jira etc.
  • Perform complete functional testing of the application and ensure the requirements are implemented correctly

Education & Experience

Overall the position requires familiarity with a variety of the field’s concepts, practices, and procedures. It also relies on extensive experience and judgment to plan and accomplish goals. The position requires at least 3+ years of experience in the field or in a related area. The candidate should have good communication, be detailed oriented and quick to learn.

  • Undergraduate or higher degree, preferably in Business, Analytics, or related field
  • More than three (3) years of relevant work experience
  • Ability to work independently as well as function as part of a team
  • Understanding of Agile Methodology
  • Release management and planning experience
  • Creative solving of technical problems–to ensure the translation of technical requirement test plans
  • Ability to focus on deadlines and deliverables, to find the bad defects and bugs
  • Ability to communicate clearly to stakeholders and users
  • Proficiency in Quality Management Software and processes
  • Knowledge and experience in technical aspects of software solution being tested
  • Business process and domain understanding

Skills and Competencies

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

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

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 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

  • Practices good internal and external customer service
  • Responsible for scientific medical writing and producing high quality documents
  • Demonstrates strong understanding of ICH guidelines, as applicable to medical writing
  • Creates medical writing training exercises, trains new medical writers, and serves as a mentor
  • Trains via self-study and self-practice independently and explores advanced topics related to medical writing and/or drug development
  • Excellent understanding of MS Word for advanced writing techniques
  • High proficient with styles of writing for various document types
  • Expert proficiency with client templates & style guides
  • Interacts directly and independently with client to coordinate all facets of projects; competent communicator
  • Highly competent review of blinded data tables, listings, and graphs for study report writing
  • Writes documents independently, with skill and proficiency
  • Addresses client comments during document lifecycle, including critical review of comments and value-added suggestions
  • Assumes responsibility for quality and integrity of documents
  • Independently implements and validates QC findings in compliance with NC Handling Procedure
  • Conducts thorough review of his/her documents prior to release to client; serves as high level reviewer for documents produced by his/her colleagues
  • Follow processes related to project management processes as appropriate for medical writing projects
  • Demonstrates extensive knowledge of departmental processes
  • Takes initiative to suggest and implement departmental process improvements
  • Leads some projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client
  • Develops excellent internal and external leadership skills for projects
  • Complies with Document and Record Control Procedure
  • Ensures compliance to applicable policies and procedures

Education & Experience

Education:

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

Experience:

  • Minimum 5-7 years of relevant Medical/ Scientific writing required
  • Familiar with the Life Sciences Industry, preferably Regulatory Services
  • 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
  • Strong hands-on experience with clinical trials and pharmaceutical development in the pharmaceutical or CRO industry
  • Ability to work independently

Skills and Competencies

Technical / Functional Skills:

  • Experience with the core medical /scientific writing activities and knowledge of protocol, CSR, IB, eCTD and regulatory requirements
  • Has high level knowledge of drug development as pertains to medical writing; has the ability to apply drug development knowledge during production of high quality documents
  • Excellent medical/scientific writing skills
  • Experience with document templates and style guidelines such as AMA, QRD
  • Strong resource for medical/scientific writing; willing to guide others in a variety of authoring and reviewing techniques
  • Proficiency with MS Office applications

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
  • A flexible attitude with respect to work assignments and new learning.
  • Ability to prioritize and manage multiple projects
  • Familiarity with ISO 9001:2008 requirements

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

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

Regulatory Services Delivery Head – India

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

Roles & Responsibilities

  • Set up, expand and manage the growing 50+ services team to deliver various Regulatory Affairs related services
  • Involvement in worldwide practice development activities
  • Generate & manage work plan, key deliverables, resources required, 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
  • Monitor and report the progress against the Service Delivery Plan
  • Assure and improve the quality of the service and maintain accurate account information
  • 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 regular basis Celegence management team with KPI details.
  • Build delivery team by supporting interview, on-board process including training for 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
  • Define Operating and Delivery Model for BPaaS this should include but not limited to the list below
  • Work with Quality Control team on different process areas related to service delivery
  • Adopt and improve existing service delivery process in the context of BPaaS
  • Define new processes for service delivery, setting up SLA and KPI for reach processes
  • Process areas to be considered – Quality Management, Communication, Governance, and Training and Continuous skill set improvement plan, Resource management, Data Security and Protection. Set strategy for the BPaaS offering within Regulatory
  • 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 KPI and Goals for India delivery center
  • 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 10 years of relevant experience
  • Familiar with the Life Sciences Industry, preferably Regulatory Affairs
  • Understanding of global regulations related Pharmaceutical, Medical Device, 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
  • Able to travel up to 30% of time including to Europe and US
  • Fluent in English

Skills and Competencies

Technical Skills:

  • Project Management

Non Technical 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 solving skills

Traits:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Drive to deliver superior quality proposals
  • Strong Time management
  • Good Stakeholder management
  • Strong Project management and tracking
  • Positive Attitude
  • Leadership Skill
  • Initiative and Commitment
  • Detailed Oriented
  • Team player
  • Focused and sincere

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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