Sr. Exe
3 days ago
Job Responsibilities:
Overall Responsibilities:
Compiling all the relevant information necessary to prepare best regulatory dossier (M1 to M5) for registration of a new vaccine or a license update in all concerned row countries including WHO Prequalification.
Developing and maintaining the Regulatory Dossier Module 1 to Module 5 keeping the document updated throughout the life of the project/product. Ensuring the coordination with the different areas concerned: Clinical Development, Product Development, Marketing and CMC related functions.
Participating and performing change control assessment (CCRs) of any necessary changes and implementation plan with a global view for the impacted product(s). Filing of relevant Post approval Change (Variation).
Primary Responsibilities:
- Marketing Authorization Applications (Preparation of dossiers for registration in ROW countries in CTD/ACTD/eCTD)
- Application for Post Approval Change(s)/Renewal
- Maintenance of Documentation Data base available with vaccine IRA.
- Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing.
- Review of Pack Profiles.
- Review of Artworks (Labels and Package Insert).
- Preparation / compilation of technical documents related to tenders / queries.
- Arranging Samples required for registration
Secondary Responsibilities:
- To ensure continuous improvement in the quality of registration documents, internal systems and processes.
- Responsible for notification to relevant functional areas and impacted project team(s) regarding communications/feedback from regulatory authority
- Vaccine Regulatory Intelligence, Sharing vaccine regulatory updates.
Profile Preference:
- Masters degree in Microbiology/ Biotechnology/Pharma
- Experience in R&D or Quality Assurance or Quality Control of vaccine & Biologicals shall be considered
- Proficient in MS Word, Excel, PDF, PowerPoint
- Experience in preparation of regulatory responses.
- Strong written and verbal communication skill
- Strong organization skills
- Strong Regulatory knowledge and demonstrated application shall be very helpful
- Strong background in biologics/vaccine/drug development, manufacturing, or testing
- Demonstrated ability to work successfully on global project teams.
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