Officer/Sr. Officer-Regulatory Affiar
Exemed Pharmaceuticals
Vadodara, Gujarat, India
Posted on 28-07-2025
1 Vacancy
Description
- Prepare, compile, and submit regulatory dossiers for domestic and international markets.
- Coordinate with cross-functional teams (QA, QC, R&D, Production) for required technical data.
- Ensure timely submission of product registration, renewals, and post-approval changes.
- Review product labeling, artwork, and promotional materials for regulatory compliance.
- Stay updated with country-specific regulatory guidelines (CDSCO, USFDA, EMA, WHO-GMP, etc.).
- Respond to regulatory authority queries and deficiency letters within deadlines.
- Maintain records of licenses, dossiers, and correspondence with regulatory bodies.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Preferred Education
MPharm (Master Of Pharmacy)BPharm (Bachelor Of Pharmacy)
Key Skills
Attention to DetailProblem SolvingTeam WorkCommunication
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