Overview

Director, Regulatory Affairs (Virology) – Global Regulatory Affairs at Gilead Sciences. Develops and executes regulatory strategies for products across the virology portfolio in alignment with global regulatory strategies, in collaboration with Franchise Leads and cross-functional stakeholders, in compliance with applicable regulations. The role may serve as Global and/or Regional Regulatory Lead on complex products, compounds, indications, or projects, and may manage a portfolio of virology projects while supporting programs in other therapeutic areas as needed. Leads Regulatory Submissions Teams or similar cross-functional teams and contributes to the development of regulatory capabilities and talent.

Responsibilities

• Accountable for a broad spectrum of regulatory activities and deliverables for virology products, indications, or projects.
• Represent Gilead in negotiations with regulatory authorities; may serve as a direct contact with local authorities.
• Address extremely complex problems and provide impactful solutions.
• Contribute to development and refinement of regulatory strategies, processes, standards, and capabilities.
• Lead Regulatory Affairs representation on cross-functional/ cross-regional Teams; provide strategic guidance to Regulatory Affairs and cross-functional leaders.
• Advise on short- and long-range regulatory strategies, plans, resources, and tactics in cross-functional meetings (program strategy, global development teams).
• Participate in or supervise sub-teams (Study Management, Clinical, Nonclinical, Biomarkers) as needed and guide sub-team participation.
• Define, oversee, and communicate regulatory strategy for assigned products or projects; identify regulatory risks and mitigation plans.
• Oversee preparation and maintenance of regulatory submissions, labeling, and packaging; ensure compliance and timely filing (e.g., INDs, NDAs, DSURs, IB updates).
• Oversee authoring and approval of regulatory documents (e.g., module documents for original IND/NDA, meeting requests).
• Oversee labeling, packaging, and information updates per product licenses; critically review submission documents.
• Provide input on resource plans and track resources and budgets; ensure compliance with practices, policies, and regulatory requirements.
• Mentor Regulatory colleagues and regional leads; contribute to building the Regulatory Liaison team.

Qualifications

U.S. Education & Experience

• PharmD/PhD with 8+ years’ relevant experience; MA/MS/MBA with 10+ years; BA/BS with 12+ years.
• Extensive regulatory, quality, compliance experience in biopharma; success directing regulatory strategy for multiple products.
• Experience in cross-functional projects related to clinical trials or drug development; experience negotiating with regulatory authorities.
• Line management experience strongly preferred; proven leadership and matrix management capabilities; track record of managing large, complex projects.
• Experience with one or more Gilead therapeutic areas and drug development stages preferred.

Rest Of World Education & Experience

• BA/BS or advanced degree in life sciences with significant regulatory experience in biopharma or related field; experience with in vitro diagnostic development strongly preferred.

Knowledge & Other Requirements

• Expert knowledge of drug development process and global/regional regulatory requirements for medicinal products; understanding of HA interactions.
• Strong leadership, interpersonal, communication, and organizational skills; ability to influence programs and initiatives; travel as needed.

Salary and Benefits

The Salary Range For This Position Is: Bay Area: $210,375.00 - $272,250.00; Other US Locations: $191,250.00 - $247,500.00. Gilead offers discretionary bonus, stock-based incentives, benefits including medical, dental, vision, life insurance, paid time off, and other well-being programs. Benefits information available at the company compensation/benefits portal.

Additional Information

Gilead Sciences is an equal employment opportunity employer. Reasonable accommodations available to applicants with disabilities upon request. Internal candidates should apply via the Workday portal.