Manager-regulatory Affairs

Galderma

India
Not specified
8 to 10 years regulatory affairs experience
Dcgi liaison for product approvals
Form 44 and form 40 submission expertise
Galderma is seeking a Manager of Regulatory Affairs in India, responsible for ensuring compliance with regulations while developing strategies for the company’s regulatory needs. The ideal candidate should have 8-10 years of relevant experience and a strong background in regulatory affairs, alongside skills in communication, personal effectiveness, and strategy

Job Summary

  • The role is responsible for ensuring Galderma India adheres to applicable regulations under the supervision of the Lead – Medical & Regulatory Affairs.
  • Key responsibilities include liaising with DCGI officials for product marketing approvals, import permissions, and clinical trial protocol clearances.
  • The position requires developing strategies for regulatory compliance, managing pharmacovigilance activities, and reviewing packaging artworks from a regulatory perspective.

Matching Summary

Match Score: 85

Galderma is seeking a Manager of Regulatory Affairs in India, responsible for ensuring compliance with regulations while developing strategies for the company’s regulatory needs. The ideal candidate should have 8-10 years of relevant experience and a strong background in regulatory affairs, alongside skills in communication, personal effectiveness, and strategy.

Skills & Requirements

Must-have

  • 8 to 10 years Regulatory Affairs experience
  • DCGI liaison for product approvals
  • Form 44 and Form 40 submission expertise
  • Clinical trial protocol approval coordination
  • Manufacturing license facilitation with State FDA

Nice-to-have

  • Master's degree in Pharma or Science
  • Leadership skills inspiring high performance
  • Passion for dermatology market growth
  • Strong teamwork and collaboration abilities

Key Requirements

  • Bachelor's Degree in Pharma or Science
  • 8 to 10 years of Regulatory Affairs experience
  • Proficiency with MS Office suite

Work Rights

Not specified

Tailored Resume

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