Officer/Sr. Officer-Regulatory Affiar

Officer/Sr. Officer-Regulatory Affiar

work outline icon2 - 6 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Exemed Pharmaceuticals

time outline iconVadodara, 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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