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, a