Deputy Manager-Regulatory affairs

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Deputy Manager-Regulatory affairs

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

Naari Pharma Private Limited

time outline iconNoida, Uttar Pradesh, India

Posted on 29-08-2025

1 Vacancy

Description

  • Lead preparation, review, and submission of regulatory dossiers (CTDs, DMFs, ANDAs) for product approvals.
  • Ensure compliance with global and local regulatory requirements (USFDA, EMA, WHO, CDSCO, etc.).
  • Coordinate with R&D, QA, QC, and Production teams for regulatory data and documentation.
  • Respond to regulatory queries, deficiency letters, and inspections efficiently.
  • Monitor and implement changes in regulations affecting products and submissions.
  • Support strategic planning for product development, registration, and lifecycle management.
  • Maintain regulatory databases, files, and documentation systematically.
  • Mentor and guide junior regulatory affairs team members.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Preferred Education

MPharm (Master Of Pharmacy)

Key Skills

Attention to DetailCommunicationFinanceProblem Solving

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