Deputy Manager-Regulatory Affairs

institute logo

Deputy 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

  • Lead and oversee preparation, review, and submission of regulatory dossiers (CTD/eCTD).
  • Ensure compliance with global regulatory guidelines (USFDA, EMA, MHRA, CDSCO, WHO, etc.).
  • Manage product registrations, renewals, post-approval changes, and lifecycle management.
  • Liaise with regulatory authorities and respond to queries/deficiencies effectively.
  • Collaborate with R&D, QA, QC, and Production teams for timely data compilation.
  • Review labeling, packaging, and promotional materials for regulatory compliance.
  • Monitor global regulatory updates and implement changes within the organization.
  • Mentor and train team members on regulatory processes and best practices.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Good CommunicationAttention to DetailDecision-MakingProblem Solving Skills

Aggregated job.

Learn more