Director, Regulatory Affairs Global Labeling

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Regulatory Affairs Global 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 Global 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 oversight of regulatory labeling activities for multiple highly complex or large-scale products or all products within the assigned therapeutic area(s). You will develop the labeling strategy for multiple products. You will lead 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 may manage, oversee, review, and approve the work of a team of direct reports, and may manage other people leaders. However, this role is an individual contributor.

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 assist with cross-functional meetings involved in the governance and decision-making of regulatory labeling. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You may train cross-functional partners and teams on labeling processes, policies, procedures, standards, etc.

EXAMPLE RESPONSIBILITIES:

• This role is an individual contributor, and may manage direct report(s).
• May be a standing member of the RA Labeling Leadership Team.
• Leads development of the labeling strategy for multiple products and indications.
• Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across one or more therapeutic areas.
• Provides strategic advice and guidance to cross-functional partners and stakeholders.
• 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 team and/or 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.
• 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 6+ years’ relevant experience.
• MA/MS/MBA with 10+ years’ relevant experience.
• BA/BS with 12+ years’ relevant experience.
• 6+ years’ experience in prescription drug labeling.
• Significant experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple medicinal products.
• Proven track record in effectively setting and directing the regulatory labeling or related strategy to successful conclusion for one or more products.
• Significant experience working with a broad array of regulatory labeling documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products.
• Significant experience in NDA/BLA labeling and labeling negotiations.
• Strong track record of successes working and negotiating with regulatory authorities.
• Global prescription drug label experience, U.S., EU, and potentially more.
• Extensive experience participating in cross-functional projects and teams.
• Proven track record of effective people leadership as evidenced through cross-functional team engagement.
• Proven track record of successfully managing large scale, complex, time-sensitive projects.
• Experience working with one or more Gilead 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.
• 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 ability to rapidly learn new therapeutic areas.
• 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, understanding and effectively advising on regulatory implications.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects, and/or initiatives.
• Strong 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.
• Strong negotiation and conflict resolution skills.
• Strong coaching capabilities to mentor cross-functional teams and colleagues.
• When needed, ability to travel.

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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