Director, Regulatory Affairs

Gilead Sciences

Bogota, Colombia
**
Lead regulatory activities
Ensure applicant responsibilities
Prepare complex submissions
** Gilead Sciences is seeking a Director of Regulatory Affairs in Bogota, Colombia, to lead regulatory activities for assigned projects and territories, ensuring compliance with ICH and regional requirements. The ideal candidate should have over 12 years of experience in Regulatory Affairs and possess strong leadership and negotiation skills. **

Job Summary

  • Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  • Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories.
  • Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.

Matching Summary

Match Score: 75

** Gilead Sciences is seeking a Director of Regulatory Affairs in Bogota, Colombia, to lead regulatory activities for assigned projects and territories, ensuring compliance with ICH and regional requirements. The ideal candidate should have over 12 years of experience in Regulatory Affairs and possess strong leadership and negotiation skills. **

Skills & Requirements

Must-have

  • lead regulatory activities
  • ensure applicant responsibilities
  • prepare complex submissions
  • maintain product licenses
  • interact with regulatory authorities
  • develop regulatory strategy
  • lead submission teams

Nice-to-have

  • create a healthier world
  • drive scientific innovation
  • foster inclusive environments
  • contribute to new guidance

Key Requirements

  • 12+ years of experience in Regulatory Affairs
  • Degree in a scientific field preferred
  • Extensive knowledge of regulatory requirements
  • Excellent verbal, written, negotiation and interpersonal communication skills

Work Rights

Not specified

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