Manager - International Regulatory Affairs - Pharma

MANAGER-REGULATORY AFFAIRS INTERNATIONAL

Responsibilities:

- Preparation and reviewing of CTD and ACTD dossier.

- Coordination with Plant and R&D to collect inputs required for Regulatory Submission.

- Co-ordination 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.

- Gather feedback from all the countries for respective variation, and ensure timely submission.

- Handle renewals.

- Updating Master data.

- Follow-ups with plant for documentation regularly and review meetings.

- Tracking and reviewing document requirements for upcoming new filings in ROW and Emerging markets

Knowledge and skills:

- eCTD, CTD, Validation, ICH requirements, USFDA Filings,WHO Prequalification, MCC South Africa for Biological and Biotech products

Education:

M.Pharma/MSc.Biotech

Experience: 6-8 years