Manager-regulatory Affairs

70

India
8 to 10 years regulatory affairs experience
Dcgi liaison and approval management
Form 44 nda submission expertise
The role is responsible for ensuring Galderma India adheres to applicable regulations under the supervision of the Lead – Medical & Regulatory Affairs

Job Summary

  • The role is responsible for ensuring Galderma India adheres to applicable regulations under the supervision of the Lead – Medical & Regulatory Affairs.
  • Candidates must manage DCGI liaisons for product marketing approvals, registration certificates, and import permissions while coordinating clinical trials.
  • The position requires developing standard operating procedures and policies while representing the company in professional association committees like OPPI.

Matching Summary

The role is responsible for ensuring Galderma India adheres to applicable regulations under the supervision of the Lead – Medical & Regulatory Affairs.

Skills & Requirements

Must-have

  • 8 to 10 years Regulatory Affairs experience
  • DCGI liaison and approval management
  • Form 44 NDA submission expertise
  • State FDA manufacturing license facilitation
  • Clinical trial protocol coordination

Nice-to-have

  • Master's degree in Pharma or Science
  • Leadership skills inspiring high performance
  • Experience with global healthcare environment
  • Proficiency in MS Office suite
  • Passion for dermatology market growth

Key Requirements

  • Bachelor's Degree in Pharma or Science
  • 8 to 10 years of Regulatory Affairs experience
  • Master's degree (added advantage)

Work Rights

Not specified

Tailored Resume

Cover Letter