Regulatory Affairs Officer

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Regulatory Affairs Officer

work outline icon1 - 5 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

ICPA Health Private Limited

time outline iconAnkleshwar, Gujarat, India

Posted on 01-09-2025

1 Vacancy

Description

  • Prepare, compile, and submit dossiers for product registration in domestic and international markets.
  • Ensure compliance with regulatory guidelines (CDSCO, USFDA, EMA, WHO, etc.).
  • Review technical documents, labels, and packaging for regulatory accuracy.
  • Coordinate with R&D, QA, and production teams for regulatory submissions.
  • Handle queries and deficiency letters from regulatory authorities.
  • Maintain updated knowledge of global regulatory requirements.
  • Support product lifecycle management, renewals, and variations.
  • Ensure timely approvals for new products and amendments.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Good Communication SkillsAttention to DetailDecision MakingProblem Solving

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