About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For over 35 years, Gilead has pioneered therapies for some of the world's most challenging diseases, including HIV, viral hepatitis, COVID-19, and cancer. Our relentless pursuit of innovation has resulted in life-changing treatments that improve lives and ensure global access to cutting-edge medicine. Today, Gilead continues to tackle oncology, inflammatory diseases, and emerging health threats through bold scientific advancements and collaborative efforts. With a mission-driven culture, we empower our teams to push boundaries and make a tangible difference in patient outcomes worldwide.

Role Overview

As the Executive Director, Regulatory Affairs - Combination Products & Devices at Gilead Sciences, you will provide strategic leadership for global regulatory strategies in combination products and devices. This senior role involves championing innovation to accelerate development timelines, guiding cross-functional teams, and ensuring compliance with evolving health authority requirements. Reporting into the global CMC Regulatory Affairs organization, you will drive enterprise-wide collaboration in a matrixed environment, overseeing late-stage programs, regulatory submissions, and lifecycle management. This position is pivotal in aligning device and combination product development with Gilead's ambitious goals in HIV therapies, oncology, and inflammatory disease treatments.

Strategic Impact

Your expertise will shape regulatory paths for innovative therapies, integrating FDA 21 CFR Part 4 standards, ICH guidelines, and global technical requirements. From early-stage Target Product Profiles (TPPs) to NDA/BLA approvals, you will influence product strategies that bring breakthrough medicines to market faster.

Key Responsibilities

In this role, you will define and drive global regulatory strategies for combination products, ensuring alignment with corporate objectives and regulatory expectations. Key duties include leading CMC regulatory initiatives, fostering collaboration across Quality, Manufacturing, Technical Development, Clinical Development, and Supply Chain functions. You will provide oversight for regulatory operations, including drafting CMC sections for filings, managing agency interactions, and preparing for inspections. Additionally, offer strategic input on Design Control processes, design history files, human factors studies, and process characterization to support commercialization readiness.

• Champion regulatory innovation and novel approaches to expedite approvals.
• Guide Product Development and Device Teams on integrated regulatory paths.
• Influence cross-functional decision-making in a matrixed organization.
• Lead major regulatory applications and lifecycle management for early and late-stage programs.
• Model Gilead's Core Values, fostering a culture of integrity and excellence.

Qualifications & Requirements

Candidates must hold a scientific degree with at least 16 years of directly relevant experience in small molecule and biologics development, global CMC regulatory affairs, and technical areas (or 14 years with MA/MS, PhD, PharmD, or MD). A proven track record in leading CMC initiatives, innovative strategies, and participation in international forums like ICH, PhRMA, ISPE, IQ, and Bios is essential. Experience with NDA/BLA submissions, global health authority interactions, IND/IDE filings, and product inspections is required. Deep understanding of ICH guidelines, GMP requirements, and device technologies is critical, alongside exceptional strategic acumen, collaboration, communication, and leadership skills.

Leadership Expectations

Demonstrated success in leading complex groups, applying sound judgment, and driving operational goals in enterprise settings. Proven ability to innovate in device development and champion business improvements.

Benefits & Perks

Gilead Sciences offers a comprehensive benefits package designed to support your well-being and professional success. Enjoy competitive salaries with performance incentives, robust health insurance, retirement plans, and generous paid time off. Our wellness programs, flexible work options, and family support benefits promote work-life balance. Invest in your growth through tuition reimbursement, leadership development, and access to cutting-edge training resources.

Career Growth

At Gilead, career advancement is a priority. As a People Leader, you will evolve our inclusive culture, empowering teams to achieve aspirations. This role offers visibility across global functions, positioning you for broader enterprise leadership. With opportunities in HIV, oncology, and inflammatory diseases, you will contribute to high-impact programs and build a legacy of innovation.

Why Join Gilead

Joining Gilead means becoming part of a passionate team fighting the world's biggest health challenges. Our collaborative environment, commitment to diversity, and focus on employee development make us an employer of choice in biopharma. Work on groundbreaking therapies in HIV, oncology, and inflammatory diseases, with the resources to make a direct impact. Every role at Gilead plays a critical part in our bold ambitions—yours will too.

Role FAQs

What experience is required?

16+ years with BA/BS or 14+ with advanced degree in CMC regulatory affairs for small molecules, biologics, and devices.

Is travel involved?

Yes, for global health authority interactions and cross-functional meetings.

What makes this role unique?

Focus on combination products/devices in a fast-paced biopharma leader advancing HIV, oncology, and inflammation therapies.

How does Gilead support leadership development?

Through People Leader training, core values alignment, and enterprise-wide opportunities.

This premium opportunity at Gilead Sciences awaits ambitious leaders ready to drive regulatory excellence. Apply today to help create possible, together.