JOB DESCRIPTION Job / Position Title:
Function / Department: Regulatory Affairs-International
Position Reports To:
Positions Reporting Directly to
Primary Purpose of the Position: ESSENTIAL DUTIES/
RESPONSIBILITIES OF THE
POSITION: 1. Preparation and reviewing of CTD and ACTD
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
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 there timely submission.
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 KNOWLEDGE/ SKILLS/
ABILITIES eCTD, CTD, Validation, ICH requirements, USFDA Filings,
WHO Prequalification, MCC South Africa for Biological and
MINIMUM YEARS OF
EXPERIENCE 6-8 years
KNOWLEDGE Skills - eCTD, CTD, Validation, ICH requirements, EMA Filings
Airoli, Navi Mumbai, Maharashtra, India