Job Description

Overview

Associate Director, Regulatory Affairs - Global Labeling

Location: United States - California - Foster City. Employment type: Full time. Posted 18 Days Ago. Requisition id: R0045154.

At Gilead, we strive to create a healthier world by tackling HIV, viral hepatitis, COVID-19 and cancer, and by ensuring access to therapies globally. We seek passionate and ambitious people to join our mission and collaborate to make a difference.

Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a strategic partner across cross-functional teams. This group creates, updates, and maintains product information and labeling documentation to ensure ongoing regulatory compliance. Labeling materials include product use, benefits, dosage, safety information for patients and healthcare providers, and related guidelines. The team collaborates with Development, Legal, Commercial, and external regulatory agencies to deliver timely labeling updates.

Job Description

You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic area. You will lead various Core Labeling Working Group (CLWG), Target Product Label (TPL), and U.S. Product Information (USPI) team meetings. You will represent Regulatory Affairs Labeling across organizational levels for assigned products. You will manage, oversee, review, and approve the work of direct reports. You will manage complex labeling negotiations with regulatory authorities and communicate updates to cross-functional leaders and teams. You will contribute to ad hoc or special projects to advance Regulatory Affairs capabilities and train cross-functional partners on labeling processes, policies, and standards.

Key Responsibilities:

• Individual contributor with potential leadership opportunities to mentor and coach others.
• Leads or contributes to the development of labeling strategy for multiple products and indications.
• Oversees and guides the preparation and maintenance of regulatory labeling for multiple products in Virology.
• Provides strategic advice to cross-functional partners and stakeholders.
• Leads cross-functional labeling forums and meetings (CLWG, TPL, USPI).
• Leads or contributes to system and process improvements.
• Represents RA Labeling on RA Project Teams and cross-functional meetings with partner companies.
• Oversees CCDS/USPI review, approval, distribution, and tracking; ensures CCDS updates are reflected in USPI.
• Oversees and guides U.S. labeling review in SPL format, artwork requests, labeling document archiving, and label histories; leads ex-U.S. labeling reviews as needed.
• Manages complex labeling negotiations with regulatory authorities.
• Coaches less experienced colleagues and fosters regulatory capability development.
• Leads or contributes to special projects to advance Regulatory Affairs capabilities.
• Trains RA Labeling colleagues or cross-functional teams in labeling matters.
• Ensures work complies with established practices, policies, and regulatory requirements.

Preferred Qualifications:

We value diverse contributions to serve patients. See the qualifications below:

Preferred Education & Experience

• PharmD/PhD with 2+ years' relevant experience.
• MA/MS/MBA with 8+ years' relevant experience.
• BA/BS with 10+ years' relevant experience.
• 4+ years' experience in prescription drug labeling.
• Significant regulatory labeling experience in the biopharma industry preferred.
• Experience with regulatory labeling documentation and processes (CCDS, prescribing information, TPL) for marketed and investigational products.
• Experience contributing to labeling strategy, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams.
• Experience in NDA/BLA labeling and labeling negotiations.
• Experience participating in cross-functional projects and teams.
• Experience authoring and implementing processes.
• Line management experience (direct reports).
• Experience across one or more Gilead therapeutic areas and various stages of drug development is strongly preferred.

Knowledge & Other Requirements

• In-depth knowledge of labeling requirements and guidance, including industry best practices and standards.
• Strong understanding of CCDS/USPI and competitor labeling; broad therapeutic area knowledge.
• Ability to rapidly learn new therapeutic areas.
• Knowledge of global/regional regulatory trends to inform strategies.
• Thorough knowledge of the drug development process from research through post-marketing.
• Advanced regulatory and business knowledge with strong analytical abilities for multidisciplinary data and regulatory implications.
• Strong leadership presence and ability to influence programs without direct authority.
• Strong interpersonal, communication, and organizational skills.
• Strong negotiation and conflict resolution skills.
• Willingness and ability to travel when needed.

People Leader Accountabilities:

Create inclusion by valuing diverse teams and embedding inclusion in management practices.

Develop talent by coaching employees on performance, potential, and career growth.

Empower teams by aligning goals and providing support to remove barriers and connect to the broader organization.

Salary and Benefits

The salary range for this position is $182,070.00 - $235,620.00. Compensation is determined by experience, qualifications, and location. This role may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (availability varies by role), paid time off, and a benefits package including medical, dental, vision, and life insurance plans. Benefits information is available on the company site.

For more information about benefits, visit the benefits page for eligible employees.

Equal Employment Opportunity

Gilead Sciences Inc. is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, or other protected characteristics. Reasonable accommodations are available for applicants under Section 503 of the Rehabilitation Act, the Vietnam Era Veterans Readjustment Act, and the Americans with Disabilities Act. Applicants may contact the company for accommodation requests.

Note : This posting may include additional notices and information required by law; some sections appear for regulatory purposes and vary by location. Please apply via the Internal Career Opportunities portal in Workday for current employees.

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