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 breakthroughs in treating some of the world's most challenging diseases, including HIV, viral hepatitis, COVID-19, and cancer. Our relentless pursuit of innovative therapies has transformed lives globally, ensuring access to life-changing medicines. Headquartered in Foster City, California, Gilead employs thousands of passionate professionals united by a mission to advance scientific discovery and development. We tackle inflammatory diseases and oncology alongside our virology expertise, fostering collaboration, determination, and bold ambition. Joining Gilead means contributing to therapies that address unmet medical needs and make a tangible difference in patients' lives.

Role Overview

The Sr Manager, Regulatory Affairs - Virology position at Gilead Sciences is a pivotal leadership role within our Global Therapeutic Area Regulatory team. Based in either Foster City, CA, or Parsippany, NJ, you will serve as the Regional Regulatory Lead for assigned virology products, compounds, indications, or projects. This role involves defining regulatory strategies, leading cross-functional submission teams, and interacting with regulatory authorities. With products of increasing complexity, you will coach junior colleagues, drive process improvements, and ensure compliance with global standards. Ideal for seasoned regulatory professionals passionate about virology—think HIV and hepatitis therapies—this position offers a platform to shape the future of Gilead's pipeline.

Why Regulatory Affairs at Gilead?

In virology, where speed and precision are critical, your expertise will accelerate therapies from development to market, impacting millions worldwide.

Key Responsibilities

As Sr Manager, Regulatory Affairs - Virology, your core duties include representing regional Regulatory Affairs on cross-functional teams, defining strategies for Gilead products, and leading submissions like INDs, amendments, and DSURs. You will proactively identify risks, develop mitigation plans, and ensure timely filings. Additional responsibilities encompass authoring regulatory documents, providing label input, maintaining product packaging compliance, and critically reviewing submissions. You will also initiate process improvements and coach less experienced team members, fostering a culture of excellence and innovation.

Leadership and Collaboration

Lead without authority across clinical, nonclinical, and study management sub-teams, driving Gilead's virology ambitions forward.

Qualifications & Requirements

Basic qualifications include a Doctorate with 2+ years of relevant experience, a Master’s with 6+ years, or a Bachelor’s with 8+ years. Preferred candidates bring significant regulatory, quality, or compliance experience in biopharma, ideally with Gilead's therapeutic areas like virology across drug development stages. Key attributes: experience setting regulatory strategies, leading submissions, authoring processes, and demonstrating adaptability. Advanced knowledge of ICH standards, regional requirements, and regulatory affairs' role in drug discovery is essential. Be a fast learner, flexible, and capable of managing complex projects while mentoring others.

Preferred Experience in Virology

Strong preference for hands-on work with HIV, hepatitis, or similar antivirals, from IND to commercialization.

Benefits & Perks

Gilead Sciences offers a premium compensation package, including a competitive salary estimated at $190,000-$240,000 annually, performance-based bonuses, and equity opportunities. Comprehensive benefits encompass medical, dental, and vision coverage, plus wellness programs supporting physical and mental health. Enjoy generous paid time off, parental leave, and flexible work arrangements. Professional development is prioritized through tuition reimbursement, leadership training, and access to cutting-edge conferences. Our inclusive culture promotes diversity, equity, and belonging, with employee resource groups and volunteer opportunities.

Career Growth

At Gilead, people leaders are cornerstones of our culture. This Sr Manager role positions you for advancement into director-level positions or broader regulatory leadership. Gain exposure to global projects, cross-functional influence, and Gilead's expansive pipeline in HIV, oncology, and inflammatory diseases. Mentoring responsibilities build your leadership skills, while process improvement initiatives showcase your impact. With a commitment to employee development, Gilead empowers you to achieve bold ambitions and evolve our innovative environment.

Pathways in Regulatory Affairs

From regional lead to global head, your trajectory aligns with Gilead's growth in virology and beyond.

Why Join Gilead

Gilead stands out for its mission-driven culture, where every team member drives life-changing innovations. Collaborate on therapies combating HIV, advancing oncology treatments, and addressing inflammatory diseases. Our Foster City and Parsippany locations offer state-of-the-art facilities, vibrant communities, and proximity to biotech hubs. Experience a supportive environment with great leaders who prioritize inclusion, development, and empowerment. Join us to fight the world's biggest health challenges, make direct impacts, and create possible together. Gilead's bold ambitions need your regulatory expertise in virology.

Role FAQs

Q: What therapeutic areas does this role focus on?
A: Primarily virology, including HIV and viral hepatitis, with potential exposure to other Gilead areas like oncology and inflammation.

Q: Is leadership experience required?
A: Yes, experience leading cross-functional teams without authority and coaching colleagues is strongly preferred.

Q: What locations are available?
A: Foster City, California, or Parsippany, New Jersey, both in the United States.

Q: Are there opportunities for process innovation?
A: Absolutely—this role includes contributing to special projects and process improvements across Regulatory Affairs.

Q: How does Gilead support career development?
A: Through training, mentoring, tuition assistance, and clear paths to higher leadership in a growing biopharma leader.