Director, Regulatory Affairs

Gilead Sciences

12+ years regulatory affairs experience
Ich and regional regulatory requirements knowledge
Submission management for clinical trials and marketing authorizations
The role involves leading all regulatory activities for assigned projects and territories in strict compliance with ICH and regional requirements

Job Summary

  • The role involves leading all regulatory activities for assigned projects and territories in strict compliance with ICH and regional requirements.
  • Candidates must be capable of developing regulatory strategies and managing complex negotiations with local Regulatory Authorities.
  • This position requires maintaining up-to-date knowledge of global trends and contributing to the preparation of new regulatory guidance.

Matching Summary

The role involves leading all regulatory activities for assigned projects and territories in strict compliance with ICH and regional requirements.

Skills & Requirements

Must-have

  • 12+ years Regulatory Affairs experience
  • ICH and regional regulatory requirements knowledge
  • Submission management for clinical trials and marketing authorizations
  • Product Company Core Data Sheets preparation
  • Negotiation with Regulatory Authorities

Nice-to-have

  • Experience leading teams in submission preparation
  • Active participation in industry trade groups
  • Proven ability to drive process improvements
  • Strong influence and interpersonal communication skills

Key Requirements

  • 12+ years of experience in Regulatory Affairs
  • Degree in a scientific field preferred
  • Expertise in ICH and regional regulatory frameworks

Work Rights

Not specified

Tailored Resume

Cover Letter