Telegram Group (3.1k Members) Join Now

Regulatory Affairs jobs Assistant Manager at Bharat Serums and Vaccines Limited

Share this Job...

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.

Regulatory Affairs jobs Assistant Manager at Bharat Serums and Vaccines Limited

Job Description:

PostAssistant Manager – Regulatory Affairs
Experience6 to 10 year(s) of experience
QualificationM. Pharm
LocationNavi Mumbai, Maharashtra
Industry TypePharma / Healthcare / Clinical research
Functional AreaRegulatory Affairs
End Date10th June 2023

Job Responsibility:

  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 variations, and their timely submission.
  8. renewals.
  9. Master data Updating.
  10. Follow-ups with the plant for documentation regularly and review meetings.
  11. 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.

Leave a Comment