BSV M Pharma Job - Regulatory Affairs - Apply Online

BSV M Pharma Job – Regulatory Affairs – Apply Online

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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 markets

Role: 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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