Gilead Sciences
Exec Director, Regulatory Affairs-Combination Products & Devices
Gilead Sciences, Washington, District of Columbia, us, 20022
Exec Director, Regulatory Affairs-Combination Products & Devices
Gilead Sciences is seeking an experienced Executive Director to lead regulatory affairs for combination products and devices. This role will define and drive global regulatory strategies, ensure compliance, and collaborate across the organization to support product development and commercialization.
Overview We have been addressing major diseases such as HIV, viral hepatitis, COVID‑19, and cancer for over 35 years. Our mission is to develop life‑changing therapies and ensure global access through collaboration, determination, and relentless drive.
Key Responsibilities
Define and drive global regulatory strategies for combination products, aligning with corporate goals and regulatory expectations.
Champion regulatory innovation and novel approaches to accelerate development and approval timelines.
Provide guidance to Product Development & Device Teams on regulatory alignment.
Lead global CMC regulatory initiatives focused on combination products and devices.
Ensure regulatory conformance and consistency across markets, maintaining compliance with evolving health authority requirements and internal governance.
Build and nurture cross‑functional relationships across Quality, Manufacturing, Technical Development, Clinical Development, and Supply Chain.
Guide late‑stage development programs and oversee regulatory applications and lifecycle management strategies.
Oversee drafting, review, and approval of CMC sections for regulatory filings.
Lead agency interactions, inspections, and regulatory responses to ensure readiness and compliance for global commercialization.
Contribute strategic input to Design Control processes and documentation, ensuring alignment with FDA 21 CFR Part 4 and global technical standards.
Model Gilead’s Core Values and foster a culture of integrity, excellence, and continuous improvement within the CMC RA organization.
Qualifications
A scientific degree and at least 16 years of global CMC regulatory affairs experience (BA/BS) or 14 years with an advanced degree (MA/MS, PhD, PharmD, or MD).
Leadership track record in CMC regulatory affairs initiatives, innovative strategies, and participation in international regulatory or industry forums (e.g., ICH, PhRMA, ISPE, IQ, Bios).
Experience leading NDA/BLA submissions and global Health Authority interactions.
Sound judgment and ability to make timely decisions.
Experience leading complex cross‑functional teams and supporting operational goals.
Strategic acumen, collaboration, and communication skills.
Supportive experience with IND/IDE, NDA/BLA filings and inspections in the US and abroad.
In‑depth knowledge of ICH guidelines, GMP requirements, and device technology commercialization.
Track record in improving organizational capabilities and influencing both internal and external stakeholders.
Understanding of regulatory requirements for combination products and devices.
Strong leadership, collaboration, and communication competencies with proven ability to drive innovation and influence organizational change.
Solid understanding of current industry trends such as QbD, comparability evaluation, scale‑up, and method validation.
Salary & Benefits US Locations: $274,550.00 – $355,300.00. Bay Area: $302,005.00 – $390,830.00.
Compensation may also include discretionary annual bonus, stock‑based incentives, paid time off, and a benefits package (medical, dental, vision, life insurance). For benefits details visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing.
EEO Statement Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants and fosters an inclusive work environment. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other prohibited grounds under applicable federal, state and local laws. Applicants requiring accommodation may contact ApplicantAccommodations@gilead.com. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. Gilead Sciences will not discriminate against employees or applicants regarding compensation information. We provide a work environment free of harassment and prohibited conduct.
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Overview We have been addressing major diseases such as HIV, viral hepatitis, COVID‑19, and cancer for over 35 years. Our mission is to develop life‑changing therapies and ensure global access through collaboration, determination, and relentless drive.
Key Responsibilities
Define and drive global regulatory strategies for combination products, aligning with corporate goals and regulatory expectations.
Champion regulatory innovation and novel approaches to accelerate development and approval timelines.
Provide guidance to Product Development & Device Teams on regulatory alignment.
Lead global CMC regulatory initiatives focused on combination products and devices.
Ensure regulatory conformance and consistency across markets, maintaining compliance with evolving health authority requirements and internal governance.
Build and nurture cross‑functional relationships across Quality, Manufacturing, Technical Development, Clinical Development, and Supply Chain.
Guide late‑stage development programs and oversee regulatory applications and lifecycle management strategies.
Oversee drafting, review, and approval of CMC sections for regulatory filings.
Lead agency interactions, inspections, and regulatory responses to ensure readiness and compliance for global commercialization.
Contribute strategic input to Design Control processes and documentation, ensuring alignment with FDA 21 CFR Part 4 and global technical standards.
Model Gilead’s Core Values and foster a culture of integrity, excellence, and continuous improvement within the CMC RA organization.
Qualifications
A scientific degree and at least 16 years of global CMC regulatory affairs experience (BA/BS) or 14 years with an advanced degree (MA/MS, PhD, PharmD, or MD).
Leadership track record in CMC regulatory affairs initiatives, innovative strategies, and participation in international regulatory or industry forums (e.g., ICH, PhRMA, ISPE, IQ, Bios).
Experience leading NDA/BLA submissions and global Health Authority interactions.
Sound judgment and ability to make timely decisions.
Experience leading complex cross‑functional teams and supporting operational goals.
Strategic acumen, collaboration, and communication skills.
Supportive experience with IND/IDE, NDA/BLA filings and inspections in the US and abroad.
In‑depth knowledge of ICH guidelines, GMP requirements, and device technology commercialization.
Track record in improving organizational capabilities and influencing both internal and external stakeholders.
Understanding of regulatory requirements for combination products and devices.
Strong leadership, collaboration, and communication competencies with proven ability to drive innovation and influence organizational change.
Solid understanding of current industry trends such as QbD, comparability evaluation, scale‑up, and method validation.
Salary & Benefits US Locations: $274,550.00 – $355,300.00. Bay Area: $302,005.00 – $390,830.00.
Compensation may also include discretionary annual bonus, stock‑based incentives, paid time off, and a benefits package (medical, dental, vision, life insurance). For benefits details visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing.
EEO Statement Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants and fosters an inclusive work environment. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other prohibited grounds under applicable federal, state and local laws. Applicants requiring accommodation may contact ApplicantAccommodations@gilead.com. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. Gilead Sciences will not discriminate against employees or applicants regarding compensation information. We provide a work environment free of harassment and prohibited conduct.
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