Asst. General Manager-Regulatory Affair

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Asst. General Manager-Regulatory Affair

work outline icon15 - 20 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

  • Lead and oversee all regulatory affairs activities, ensuring compliance with national and international regulations.
  • Develop, implement, and monitor regulatory strategies for product approvals, variations, and renewals.
  • Liaise with regulatory authorities (CDSCO, USFDA, EMA, WHO, etc.) for timely submissions and approvals.
  • Guide preparation, review, and submission of dossiers, CTD/eCTD, and other regulatory documents.
  • Ensure compliance with labeling, packaging, and promotional material as per regulatory guidelines.
  • Provide regulatory support during audits, inspections, and product development stages.
  • Collaborate with R&D, QA, QC, Production, and Marketing teams for smooth regulatory processes.
  • Monitor updates in global regulations and communicate changes to relevant stakeholders.

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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