Executive Director – Regulatory Affairs, Combination Products & Devices

Gilead Sciences

Executive Director overseeing global regulatory strategies for combination products and devices at Gilead. Fostering collaboration across functions to ensure regulatory excellence and compliance.

Posted 4/17/2026full-timeRemote • California • 🇺🇸 United StatesLead💰 $274,550 - $355,300 per yearWebsite

About the role

Key responsibilities & impact

Define and drive global regulatory strategies for combination products
Champion regulatory innovation and novel approaches to accelerate development
Lead the development of global CMC regulatory initiatives focused on combination products
Cultivate strong, collaborative relationships across Gilead’s global functions
Provide strategic direction and oversight for late-stage development programs
Oversee the drafting, review, and approval of CMC sections for regulatory filings
Provide leadership for agency interactions, inspections, and regulatory responses
Ensure readiness and compliance for global commercialization
Provide strategic input to Design Control processes and documentation
Foster a culture of integrity, excellence, and continuous improvement within the global CMC RA organization

Requirements

What you’ll need

A scientific degree with directly relevant professional experience in small molecule and biologics development
Global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD
Demonstrated track record in leading CMC regulatory affairs initiatives
Innovative CMC regulatory strategies
Experience leading NDA/BLA submission and approvals including global Health Authority Interactions
Excellent strategic acumen, collaboration, and communication skills are required
In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics
Proven track record in the successful development and commercialization of device technologies
Demonstrated organizational leadership skills at both functional and enterprise levels.

Benefits

Comp & perks

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

global CMC regulatory strategiesCMC regulatory initiativesNDA submissionBLA submissionregulatory filingsdesign control processesGMP requirementsICH guidelinesbiologics developmentsmall molecule development

Soft Skills

strategic acumencollaborationcommunication skillsorganizational leadershipinnovationintegrityexcellencecontinuous improvement

Certifications

BABSMAMSPhDPharmDMD