Regulatory Affairs Chemist

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Regulatory Affairs Chemist

work outline icon1 - 2 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

ICPA Health Private Limited

time outline iconAnkleshwar, Gujarat, India

Posted on 04-11-2025

1 Vacancy

Description

  • Prepare and review regulatory documents for product registration and approvals.
  • Ensure compliance with national and international regulatory requirements.
  • Coordinate with R&D, QA, and production teams for dossier compilation.
  • Maintain up-to-date knowledge of regulatory guidelines (e.g., CDSCO, USFDA, EMA).
  • Assist in preparing CTD/eCTD submissions and renewals.
  • Handle product variations, labeling, and technical documentation.
  • Communicate with regulatory authorities for queries and clarifications.
  • Support audits and ensure documentation accuracy.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Preferred Education

MPharm (Master Of Pharmacy)

Key Skills

Attention to DetailCommunicationTeam WorkProblem Solving

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