Regulatory Affairs jobs Assistant Manager at Bharat Serums and Vaccines Limited.
Bharat Serums and Vaccines Limited (BSV) has developed a variety of biological, biotech, and pharmaceutical goods using its scientific resources. Today, we have the luxury of being a partner of choice as we affect patient outcomes in the therapeutic areas of Women’s Health, Critical Care, and IUI-IVF.
Job Description:
| Post | Assistant Manager – Regulatory Affairs |
| 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 |
Job Responsibility:
- Preparation and reviewing of CTD and ACTD dossier.
- Coordination with Plant and R&D to collect inputs required for Regulatory Submission.
- Coordination with plant for Regulatory compliances.
- Timely achievement of monthly plan & timely query response.
- Gap Analysis/Updation of Master Data.
- Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks.
- Get feedback from all the countries for respective variations, and their timely submission.
- renewals.
- Master data Updating.
- Follow-ups with the plant for documentation regularly and review meetings.
- Tracking and reviewing of document requirements of an 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, and MCC South Africa for Biological and Biotech products.
Should have exposure to in-licensed dossier filing and out-licensing.