Sr Manager, Regulatory Affairs - Virology

Job Description

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.

You will typically act as the Regional Regulatory Lead on the assigned products, compounds, indications or projects in Virology. With guidance, you will define the regulatory strategy, plans and objectives for the assigned products or projects. You will typically lead the Regulatory Submissions Teams associated with assigned products or projects and represent Global TA Regulatory to cross-functional sub-teams. You may serve as a Gilead contact to / for regulatory authorities.

You will oversee and manage the work of less experienced colleagues supporting your work. You will coach and advise less experienced colleagues in completing their work and developing their regulatory capabilities. You will typically be assigned products, compounds, indications or projects of increasing complexity. You will also typically play a more active role in process improvements and other special projects that can carry significant value to multiple Regulatory Affairs activities and teams.

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

• Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.
• Participates on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers).
• With guidance, defines the regulatory strategy for one or more Gilead products or projects.
• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans.
• Leads 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.).
• Leads cross-functional teams in the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
• Provides input to the content of the original label and label updates.
• Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets.
• Critically reviews documents for submission to regulatory authorities.
• Initiates or otherwise contributes to process improvements and/or other special projects within Regulatory Affairs.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

• Doctorate and 2+ years of relevant experience OR
• Master’s and 6+ years of relevant experience OR
• Bachelor’s and 8+ years of relevant experience OR

• Significant regulatory, quality, compliance or related experience supporting medicinal products.
• Significant regulatory experience in the biopharma industry is strongly preferred.
• Experience setting the regulatory strategy and leading regulatory…