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Hiring companyGSK

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Manager, Regulatory Affairs

Mumbai, Maharashtra, India Full-time On-site

About the role

Regulatory Affairs team at GSK drives compliance and product lifecycle management for pharmaceuticals, vaccines, and biologics. The Manager leads end‑to‑end regulatory submissions to CDSCO, oversees labeling and artwork, and collaborates with Global Regulatory, Quality, Clinical, and Supply Chain teams. Mumbai, Maharashtra, India, on-site work model.

What you’ll do

  • Lead regulatory submissions for assigned products
  • Ensure compliance with Indian regulations and CDSCO requirements
  • Liaise with Global Regulatory, Quality, Clinical, and Supply Chain teams
  • Maintain regulatory information in Veeva Vault
  • Support QMS implementation for Regulatory Affairs
  • Evaluate regulatory intelligence and recommend actions
  • Adhere to SOPs and documentation standards
  • Manage cross‑functional stakeholder relationships

What you’ll bring

  • Bachelor's degree in Life Sciences or Pharmacy
  • 8-10 years regulatory affairs experience
  • CDSCO & SUGAM submissions
  • Product registrations and renewals
  • Clinical trial approvals
  • Licensing & import registrations
  • Regulatory compliance
  • Labeling and artwork review

Skills

Agile PlanningBusiness AcumenChange ManagementDigital FluencyLearning AgilityProblem SolvingRegulatory Strategies

Education

Bachelor's degree

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