Asst. Manager-Regulatory Affairs

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Asst. Manager-Regulatory Affairs

work outline icon8 - 10 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

H&H Healthcare And Cosmetics Private Limited

time outline iconIndore, Madhya Pradesh, India

Posted on 01-09-2025

1 Vacancy

Description

  • Assist in preparing, reviewing, and submitting regulatory documents for product approvals.
  • Ensure compliance with national and international regulatory requirements (CDSCO, USFDA, EMA, etc.).
  • Coordinate with R&D, QA, QC, and Production teams for timely data collection and dossier preparation.
  • Support compilation of CTD/eCTD dossiers, variations, and renewals.
  • Review labeling, packaging, and promotional material for regulatory compliance.
  • Maintain regulatory databases and track submission timelines.
  • Provide support during audits and regulatory inspections.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Preferred Education

MPharm (Master Of Pharmacy)BPharm (Bachelor Of Pharmacy)

Key Skills

Attention to DetailCommunicationTeam WorkProblem Solving

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