- Prepare and maintain CTD (Common Technical Document) and eCTD dossiers, where applicable.
- Coordinate current product registrations, renewals, variations, and post-approval changes.
- Prepare regulatory documents such as product registration applications, manufacturing licenses, and other regulatory submissions.
- Ensure compliance with applicable regulatory guidelines issued by CDSCO, State FDA, USFDA, EMA, and other relevant authorities, depending on the target market.
📌 Regulatory Affairs - Officer (Europe market) (South Goa)
🏢 Marksans Pharma
📍 South Goa
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