For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product information and labeling updates, including other Development teams, Legal, Commercial, and external regulatory agencies.

You will provide strategic input and operational leadership and oversight of regulatory labeling activities for all products in our oncology and cell therapy therapeutic areas. You will develop the labeling strategy for multiple products. You will lead or otherwise oversee various Core Labeling Working Group (CLWG), Target Product Label (TPL), and U.S. Product Information (USPI) team meetings. You will represent RA Labeling across all organizational levels relevant to assigned products and/or other activities. You will manage, oversee, review, and approve the work of a team of direct reports, and may manage other people leaders. You will manage complex labeling negotiations with regulatory authorities. You will serve as a central contact and expert for global Regulatory teams in interpreting content and messaging of Company Core Data Sheets (CCDSs) and USPIs, with an understanding of the nuances of ex-U.S. labeling. You will act as a key advisor to cross-functional partners, stakeholders, and teams. You will lead impact assessments on major global labeling issues. You will lead one or more teams in the preparation and submissions of USPIs as part of BLAs, sBLAs, NDAs, or sNDAs. You will routinely consult and advise cross-functional leaders on labeling strategies and pathways to achieve business goals and objectives. You may lead labeling discussions in cross-functional governance and decision-making meetings. You will influence strategic and/or corporate direction through cross-functional governance and decision-making agendas and discussions. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.

*This position will be filled at the Director or Senior Director level, based on candidate experience.

EXAMPLE RESPONSIBILITIES:

• Leads and manages a team of direct reports and may manage other people leaders. Hires, develops, and retains diverse top talent in the team. Sets clear and elevating goals for the team and individual direct reports. Coaches direct reports on their performance, development, and career interests.

• May lead or otherwise act as a standing member of the RA Labeling Leadership Team. May be a standing member of the broader Regulatory Affairs Leadership Team.

• Leads development of the labeling strategy for multiple products and indications across the oncology and cell therapy therapeutic areas.

• Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the oncology and cell therapy therapeutic areas.

• Provides strategic advice and guidance to cross-functional partners and stakeholders.

• May lead Global Safety and Labeling Committee (GSLC) labeling discussions. Influences strategic or corporate direction through GSLC labeling agenda topics and relevant background documents, by facilitating GSLC labeling discussions, and by building consensus with cross-functional leaders.

• Oversees or otherwise leads and facilitates cross-functional labeling and related forums and meetings, such as CLWG, TPL, and USPI team meetings.

• Leads or otherwise contributes to key system and process improvements.

• Represents or otherwise oversees other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on joint labeling / safety meetings with partner companies.

• Oversees and guides CCDS/USPI review, approval, distribution, and tracking. Ensures updates to the CCDS are implemented in the USPIs.

• Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories. Performs final review of ex-U.S. labeling.

• Manages complex labeling negotiations with regulatory authorities.

• Coaches and advises less experienced colleagues in completing their work and developing their regulatory capabilities.

• Leads or otherwise contributes to special projects that advance the capabilities of Regulatory Affairs.

• Trains other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling.

• Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.

• Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Education & Experience

• PharmD/PhD with 8+ years’ relevant experience.

• MA/MS/MBA with 12+ years’ relevant experience.

• BA/BS with 14+ years’ relevant experience.

• 8+ years’ experience in prescription drug labeling.

• Extensive experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional leaders and teams for multiple medicinal products.

• Extensive experience and significant successes setting and directing the regulatory labeling or related strategy to successful conclusion for multiple products.

• Extensive experience in NDA/BLA labeling and labeling negotiations.

• Strong track record of successes working and negotiating with regulatory authorities.

• Significant experience in global prescription drug labeling, U.S., EU, Australia, Canada, Japan, Switzerland.

• Extensive experience participating in cross-functional projects and teams.

• Line management (direct reports) experience.

• Extensive leadership experience and proven effectiveness, whether through direct people leadership or matrix leadership.

• Proven track record of successfully managing large scale, complex, time-sensitive projects.

• Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.

• Experience working with oncology and/or cell therapy therapeutic areas and varying stages of drug development is strongly preferred.

Knowledge & Other Requirements

• Expert knowledge of the drug development process and global and regional regulatory requirements for medicinal products.

• Expert knowledge of all key functions involved in the various stages of drug development from early research through post-marketing.

• Recognized as a regulatory expert.

• In-depth knowledge of labeling requirements and guidance, including industry best practices and standards.

• Demonstrates extensive understanding of competitor labeling, strong therapeutic area knowledge, and CCDS/USPI expertise.

• Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects.

• Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, and understanding and effectively advising on regulatory implications.

• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects, and/or initiatives.

• Exceptional interpersonal skills and understanding of team dynamics.

• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees. Able to distill complex matters into a clear business case and roadmap for execution.

• Strong negotiation and conflict resolution skills.

• Strong coaching capabilities to mentor/develop staff.

• When needed, ability to travel.

The salary range for this position is: $230,860.00 - $298,760.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.