Bharat Serums and Vaccines Limited (BSV) have used our scientific resources to develop a range of biological, biotech and pharmaceutical products. Today, as we influence patient outcomes in the therapeutic areas of Women’s health and Critical Care and IUI-IVF, we have the privilege of being a partner of choice.
Post : Assistant manager - Regulatory Affairs
Job Description
1. Preparation and reviewing of CTD and ACTD dossier.
2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.
3. Co-ordination 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 markets
Candidate Profile
M.Pharma in Any Specialization,MS/M.Sc(Science) in Biotechnology
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.
Additional Information
Experience : 6 to 10 year(s) of experience
Qualification : M.Pharm
Location : Navi Mumbai,Maharashtra
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 10th June, 2023
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