Assistant Manager Regulatory Affairs- International

Job Description

Role & 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. Tracking and reviewing of document requirements of upcoming new filing in ROW and Emerging markets Preferred candidate profile Key Skills: eCTD, CTD, Validation, ICH requirements, USFDA Filings, EMA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products. Must have exposure to in-licensed dossier filing and out licensing Candidates with 6+ years of relevant experience. Candidate must have experience on Bio pharma products