Asst Manager/ Manager- Regulatory Affairs
2 days ago
Role & responsibilities
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/Updation of Master data.
Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks.
Get feedback from all the countries for respective variation, and there timely submission.
renewals.
Master data Updating.
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
Knowledge/ Skills/ Abilities
eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products, CTD, Validation, EMA Filings.
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