Assistant manager- Regulatory Affairs
Roles and Responsibilities
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
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.
Role:Other
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Department:Other
Role Category:Other
Employment Type:Full Time, Permanent
Education
PG:MS/M.Sc(Science) in Biotechnology,M.Pharma in Any Specialization
Company Profile
Bharat Serums and Vaccines
About BSV
For over 5 decades now, we at Bharat Serums and Vaccines Ltd. have used our scientific resources to develop a range of biological, biotech and pharmaceutical products. Advent International, a global PE firm has endorsed its faith in our commitment towards bringing life to life and is partnering with us on an ambitious growth journey
Contact Company:Bharat Serums and Vaccines
Address:Airoli, Navi Mumbai.