Assistant Manager-Regulatory Affairs

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Assistant Manager-Regulatory Affairs

work outline icon1 - 3 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Beta Drugs Ltd

time outline iconBaddi, Himachal Pradesh, India

Posted on 02-09-2025

1 Vacancy

Description

  • Prepare, review, and submit regulatory dossiers (CTD/eCTD) for global markets.
  • Ensure compliance with local and international regulatory guidelines.
  • Coordinate with R&D, QA, QC, and Production for data compilation.
  • Handle product registration, renewals, and variations with regulatory authorities.
  • Maintain regulatory databases, records, and submission tracking systems.
  • Respond to regulatory queries and deficiencies in a timely manner.
  • Monitor changes in regulatory requirements and update teams accordingly.
  • Review labeling, artworks, and packaging for compliance.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Good CommunicationAttention to DetailDecision-MakingProblem Solving Skills

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