Director, Regulatory Affairs

About the role

Gilead is seeking a seasoned Director of Regulatory Affairs to lead regulatory strategy and execution for assigned products and territories. The role ensures compliance with ICH, regional regulations, and internal policies while supporting the development of life‑changing therapies.

Key responsibilities

• Lead all regulatory activities for assigned projects and territories, aligning with ICH and local requirements.
• Prepare and manage technically complex regulatory submissions, coordinating with cross‑functional teams.
• Submit and maintain clinical trial applications and marketing authorizations.
• Oversee creation and updates of Product Company Core Data Sheets (CCDS) and Core Safety Information (CCSI).
• Ensure product packaging and labeling remain compliant with licensed specifications.
• Represent the Regulatory Function in internal meetings and build relationships with regulatory authorities.
• Participate in industry groups and contribute to regulatory guidance development.

Required profile

• 12+ years of experience in regulatory affairs or a related industry.
• Degree in a scientific discipline preferred.
• Proven ability to lead complex regulatory projects across multiple regions.
• Strong communication skills for interaction with internal teams and external authorities.

Required skills

• In‑depth knowledge of ICH guidelines and regional regulatory frameworks.
• Expertise in preparing and managing clinical trial and marketing authorization submissions.
• Experience with Product Company Core Data Sheets (CCDS) and Core Safety Information (CCSI) maintenance.
• Ability to collaborate effectively with cross‑functional teams and regulatory bodies.