Clinical Project Assistant
Sanofi
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Company: DDReg Pharma
Job Type: Full Time
Location: Gurgaon
Posted: 18 hours ago
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD and eCTD documentation, regulatory compliance, and dossier preparation, particularly for EU and emerging markets.
Compliance and lifecycle management include preparation of variation and requalification dossiers and managing regulatory product maintenance across EU, UK, WHO, and other emerging markets.
Artwork and labeling review ensures annotated artwork and comparative labeling texts are accurate, consistent, and compliant with regulatory standards.
Project tracking and documentation involve maintaining trackers, task planners, product history logs, and query records to ensure timely and accurate reporting for internal and client use.
B.Pharm or M.Pharm
Gurgaon
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Sanofi
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accenture
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