Role & responsibilities : Manager/Sr. Manager-Regulatory Affairs Products : Biosimilars or Biological Products
- Preparation and reviewing of CTD and ACTD dossier.
- Co-ordination 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/Updating of Master data.
- Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks.
- Get feedback from all the countries for respective variation, and their timely submission, renewals.
- Master data Updating.
- Follow ups with plant for documentation regularly and review meeting.
- Tracking and reviewing of document requirements of upcoming current filing in ROW and Emerging markets
- Should have knowledge of eCTD, CTD, Validation, ICH requirements, USFDA Filings, EMA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products

📌 Manager/ Sr. Manager- Regulatory Affairs (Mumbai)
🏢 Selective Global Search
📍 Mumbai