BSV M Pharma Job – Regulatory Affairs – Apply Online
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Job Title: ASSISTANT MANAGER- REGULATORY AFFAIRS
Location: Navi Mumbai, Maharashtra
Eligbility Criteria: M.Pharma in Any Specialization,MS/M.Sc(Science) in Biotechnology
Desired Candidate Profile
Candidate must have knowledge of eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products.
Should have exposure to in-licensed dossier filing and out-licensing.
Roles and Responsibilities
1. Preparation and reviewing of CTD and ACTD dossier.
2. Coordination with Plant and R&D to collect inputs required for Regulatory Submission.
3. Coordination with plant for Regulatory compliances.
4. Timely achievement of monthly plan & timely query response.
5. Gap Analysis/Updation of Master data.
6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks.
7. Get feedback from all the countries for respective variation, and their timely submission.
8. renewals.
9. Master data Updating.
10. Follow ups with plant for documentation regularly and review meeting.
11. Tracking
and reviewing of document requirements of upcoming new filing in ROW and Emerging marketsRole: Other
Salary: Not Disclosed by Recruiter
Industry: Pharmaceutical & Life Sciences
Department: Other
Role Category: Other
Employment Type: Full Time, Permanent
Key Skills
- eCTD
- ValidationCTD
- EMA Filings
- ICH requirements
Apply Online
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