Job Overview
Location
United States - California - Bay Area Remote
Job Type
Full-time
Category
HR & Recruiting
Date Posted
April 18, 2026
Full Job Description
đź“‹ Description
- • As Exec Director, Regulatory Affairs-Combination Products & Devices at Gilead Sciences, you will define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations while championing innovation to accelerate development and approval timelines.
- • You will lead the development of global CMC regulatory initiatives, oversee regulatory submissions and agency interactions, provide strategic oversight for late-stage development programs, and guide cross-functional teams in Quality, Manufacturing, Clinical Development, and Supply Chain to ensure integrated execution and compliance across markets.
- • You will join a mission-driven organization dedicated to tackling global health challenges like HIV, hepatitis, cancer, and COVID-19, where scientific innovation and equitable access to therapies are central to improving lives worldwide.
- • In this role, you will model Gilead’s Core Values, foster a culture of integrity and continuous improvement, and develop your leadership impact by influencing enterprise-wide regulatory strategy without direct authority in a complex matrixed environment.
🎯 Requirements
- • A scientific degree with at least 16 years of relevant experience in small molecule and biologics development, global CMC regulatory affairs, and CMC technical areas (or 14 years with an advanced degree such as MA/MS, PhD, PharmD, or MD).
- • Demonstrated success in leading NDA/BLA submissions and approvals, including global Health Authority interactions and experience with IND/IDE filings and product-related inspections for US and foreign agencies.
- • Proven track record in leading complex groups, driving organizational capability improvements, and demonstrating strategic thinking and influencing skills internally and externally.
- • In-depth understanding of ICH guidelines, GMP requirements, and global regulatory requirements for Combination Products/Devices, including QbD, comparability, scale-up, and process validation.
- • Excellent leadership, collaboration, and communication skills, with the ability to drive innovation and influence organizational change without direct authority.
🏖️ Benefits
- • Competitive base salary ranging from $274,550.00 to $355,300.00, with eligibility for discretionary annual bonus and long-term stock-based incentives.
- • Comprehensive benefits package including company-sponsored medical, dental, vision, and life insurance plans.
- • Paid time off and access to wellbeing resources supporting work-life balance and employee health.
- • Opportunity to work remotely within the United States - California - Bay Area region, offering flexibility while contributing to global health innovation.
Skills & Technologies
Remote
Degree Required
About Gilead Sciences, Inc.
Biopharmaceutical company discovering, developing and commercializing medicines in virology, oncology and inflammation. Founded in 1987, it focuses on antiviral therapies for HIV, hepatitis B and C, COVID-19, and investigational treatments for cancer and fibrotic diseases. Operations span research, manufacturing and global access programs.
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