Executive Director, Regulatory Affairs, Labeling

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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 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 lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy and labeling operations / compliance. You will provide strategic input and operational leadership and management oversight of regulatory labeling across Gilead's product portfolio. You will oversee or otherwise lead labeling discussions in cross-functional governance and decision-making meetings. You will act as a key advisor to cross-functional partners, stakeholders, and teams. You will oversee or otherwise lead impact assessments on major global labeling issues. You will oversee or otherwise lead the establishment and maintenance of processes for ensuring global labeling compliance based on internal and external standards.

You will be a member of the Innovation, Content, and Operations (ICO) Regulatory Affairs Leadership Team with considerable responsibilities to develop, continuously improve and innovate global regulatory and labeling policies, practices, processes, tools, team, and other capabilities.

EXAMPLE RESPONSIBILITIES:

• Leads the GRA Labeling function to ensure compliance with evolving global regulatory requirements and in support of company objectives.

• Leads a team of labeling strategists who are responsible for managing core labeling (CCDSs) and US labeling (USPIs) and for oversight of regional labeling globally, for products across all Gilead therapeutic areas.

• Accountable for driving an effective and integrated cross functional governance that crosses organizational boundaries.

• Leads a team of labeling operations and compliance specialists.

• Oversee the development and management of implementation of global labeling and review processes, metrics, and systems. Provides oversight of country labeling deviations from the CCDS.