Sr. Exe / Asst. Manager - IRA Vaccine (ROW Market)

Job Responsibilities:

Overall Responsibilities:

1. 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.

2. 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.

3. 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.