Executive Director, Regulatory Affairs

Responsibilities

• Define and lead enterprise-wide regulatory strategy for precision medicine, including companion diagnostics (CDx), in vitro diagnostics (IVD), and biomarker-driven development.
• Ensure seamless integration of diagnostic and therapeutic development strategies from early discovery through global registration and commercialization.
• Represent Regulatory Affairs Precision Medicine as a subject matter expert on cross-functional teams and present to senior leadership.
• Develop and implement globally aligned precision medicine regulatory strategies to support assets from early development through registration.
• Maintain deep expertise in global diagnostic regulations (FDA, EU IVDR, PMDA, NMPA, etc.) and assess their impact on development activities.
• Lead the preparation and filing of Health Authority briefing books and coordinate pre-submission meetings.
• Manage and develop a team of Regulatory Precision Medicine professionals, providing coaching and career development.
• Identify regulatory risks and develop mitigation strategies across various therapeutic programs.
• Support due diligence, business development, and alliance management activities involving biomarkers or CDx development.

Requirements

• PharmD/PhD with 14+ years of relevant experience, or a BA/BS with 16+ years of relevant experience.
• Extensive hands-on experience in CDx/IVD regulatory strategy and submissions, including global filings and co-development with therapeutics.
• Significant regulatory, quality, or compliance experience supporting medicinal products with in vitro diagnostic development.
• Deep understanding of global policy, laws, and regulations as they apply to diagnostic development and approval (e.g., US FDA, EU IVDR).
• Strong understanding of molecular technologies and their impact on diagnostic results and clinical outcomes.
• Proven ability to lead enterprise strategy and influence senior stakeholders in a matrixed environment.
• Excellent executive presence, analytical thinking, and communication skills.

About the Company

Gilead Sciences is a research-based biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that improve lives and ensure global access to life-changing scientific innovations.