Exec Director, Regulatory Affairs
Gilead Sciences
August 20, 2026
Remote friendly (Parsippany, NJ)
United States
Corporate Functions
POSITION OVERVIEW:
The Executive Director, Head of Precision Medicine Regulatory is responsible for defining and leading enterprise-wide regulatory strategy for precision medicine, including companion diagnostics (CDx), in vitro diagnostics (IVD), and biomarker-driven development across all Gilead therapeutic areas. Ensures seamless integration of diagnostic and therapeutic development strategies from early discovery through global registration and commercialization, with direct accountability for CDx/IVD regulatory strategy and execution.
Example Responsibilities:
- Serve as subject matter expert for cross-functional/cross-regional regulatory teams on IVD development and validation.
- Develop, lead, communicate, and implement globally aligned precision medicine regulatory strategies from early development through registration; represent Gilead with health authorities as needed.
- Maintain expertise in global IVD/CDx regulations; assess and communicate impacts on development and registration.
- Provide IVD regulatory input during clinical development to ensure diagnostic compliance (e.g., FDA/IVDR).
- Lead HA briefing book preparation and pre-submission/IDE planning; provide inputs on key development/regulatory documents and labeling.
- Monitor regulatory landscape and translate into actionable enterprise strategies.
- Lead, hire, develop, and retain the Regulatory Precision Medicine team; establish enterprise frameworks/standards; identify risks and mitigation strategies.
- Support training and ensure compliance with relevant practices/policies.
Requirements:
- PharmD/PhD with 14+ years’ relevant experience OR BA/BS with 16+ years’ relevant experience.
- Significant regulatory/quality/compliance experience supporting medicinal products with IVD development experience.
- Understanding of global diagnostic policies/laws/regulations and molecular technologies.
- Extensive hands-on experience in CDx/IVD regulatory strategy and submissions; global filings and co-development.
Preferred:
- Experience working with one or more Gilead therapeutic areas and varying stages of drug development.
Compensation/Benefits:
- Salary range: $302,005.00 - $390,830.00; may include discretionary bonus/long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.
The Executive Director, Head of Precision Medicine Regulatory is responsible for defining and leading enterprise-wide regulatory strategy for precision medicine, including companion diagnostics (CDx), in vitro diagnostics (IVD), and biomarker-driven development across all Gilead therapeutic areas. Ensures seamless integration of diagnostic and therapeutic development strategies from early discovery through global registration and commercialization, with direct accountability for CDx/IVD regulatory strategy and execution.
Example Responsibilities:
- Serve as subject matter expert for cross-functional/cross-regional regulatory teams on IVD development and validation.
- Develop, lead, communicate, and implement globally aligned precision medicine regulatory strategies from early development through registration; represent Gilead with health authorities as needed.
- Maintain expertise in global IVD/CDx regulations; assess and communicate impacts on development and registration.
- Provide IVD regulatory input during clinical development to ensure diagnostic compliance (e.g., FDA/IVDR).
- Lead HA briefing book preparation and pre-submission/IDE planning; provide inputs on key development/regulatory documents and labeling.
- Monitor regulatory landscape and translate into actionable enterprise strategies.
- Lead, hire, develop, and retain the Regulatory Precision Medicine team; establish enterprise frameworks/standards; identify risks and mitigation strategies.
- Support training and ensure compliance with relevant practices/policies.
Requirements:
- PharmD/PhD with 14+ years’ relevant experience OR BA/BS with 16+ years’ relevant experience.
- Significant regulatory/quality/compliance experience supporting medicinal products with IVD development experience.
- Understanding of global diagnostic policies/laws/regulations and molecular technologies.
- Extensive hands-on experience in CDx/IVD regulatory strategy and submissions; global filings and co-development.
Preferred:
- Experience working with one or more Gilead therapeutic areas and varying stages of drug development.
Compensation/Benefits:
- Salary range: $302,005.00 - $390,830.00; may include discretionary bonus/long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.