Role & responsibilities
Prepare and maintain CTD (Common Technical Document) and eCTD dossiers, where applicable.
Coordinate recent 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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