Director, Regulatory Affairs

Overview

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.

Director, Virology Global Regulatory Affairs — regulatory strategies for products across the virology portfolio in alignment with global regulatory strategies, collaborating with Franchise Leads and cross-functional stakeholders in compliance with regulations. Acts as Global and/or Regional Regulatory Lead on complex or multiple products, compounds, indications or projects in the assigned therapeutic area. Manages a portfolio of products or projects in virology and defines regulatory strategy, plans and objectives.

May support programs across other therapeutic areas (e.g., inflammation and oncology) as needed. Leads Regulatory Submissions Teams or Regulatory Project Teams and represents Global Regulatory Affairs on cross-functional core and sub-teams. Oversees regulatory submissions, labeling, and packaging for assigned products or projects and provides operational/regulatory guidance through all stages of development to global registration and maintenance. Helps develop the Regulatory Liaison team and mentors regulatory colleagues and regional leads.

• Accountable for the successful oversight and completion of a broad spectrum of regulatory activities and deliverables for products, compounds, indications and/or other projects in the virology therapeutic area.
• Represent Gilead in negotiations with regulatory authorities as needed and serve as a direct contact with local regulatory authorities.
• Work on complex problems and provide solutions with significant impact.
• Contribute to development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
• Represent Regulatory Affairs as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams and Project Strategy Teams; provide strategic guidance to Regulatory Affairs and cross-functional leaders.
• Advise other functions on short- and long-range regulatory strategies, plans, resources and tactics in cross-functional meetings such as program strategy and global development teams.
• Participate in or guide sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) as needed.
• Define, oversee, and communicate the regulatory strategy for assigned products or projects; proactively identify regulatory risks and develop mitigation/contingency plans.
• Oversee preparation, compilation, and timely filing of regulatory submissions requiring cross-functional interactions (e.g., INDs, NDAs, DSURs, IB updates) and ensure compliance.
• Oversee authoring and approval of regulatory documents (e.g., meeting requests, Module 1 documents).
• Oversee labeling, packaging and information updates in accordance with product licenses.
• Critically review documents for regulatory submissions.
• May have direct reports; provide matrix leadership to project teams and manage resource plans and budgets.
• Ensure own work complies with established practices, policies and regulatory requirements.

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