Associate Director, Regulatory Affairs - Virology

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
 

As an Associate Director, Global Regulatory Affairs, you will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the virology therapeutic area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submission Teams or other Regulatory Project Teams and represent Global Therapeutic Area Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.

Position will be filled in either Foster City, CA or Parsippany, NJ.

EXAMPLE RESPONSIBILITIES:

• As needed, represents Gilead in negotiations with regulatory authorities.

• Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.

• Represents Regulatory Affairs and may serve as Regional Regulatory Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.

• May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.

• Defines the regulatory strategy for multiple Gilead products or projects.

• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.

• Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.).

• Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.

• Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.

• Critically reviews documents for submission to regulatory authorities.

• Provides matrix management and leadership to project teams.

• 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 own work complies 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.

U.S. Education & Experience

• PharmD/PhD with 2+ years’