Sr Manager, Regulatory Affairs

Gilead People Leader

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 Responsibilities :

• Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Responsible for submitting moderately complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs / CTAs and NDAs / MAAs for assigned territories.
• Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products and ensures that any updates to the CCDS and the Product Company Core Safety Information (CCSI) are implemented.
• Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license.
• Acts as project team representative for specified products depending on complexity of the project.
• May provide strategic regulatory advice as appropriate.
• Maintains knowledge of regulatory requirements up to date and communicates changes in regulatory information to project teams and senior management in a timely manner.
• May contribute to training of staff under direction of Senior Regulatory Affairs Professional.
• May initiate local process improvements and contribute to local and / or global process improvements, which have a moderate impact on the Regulatory Affairs function or other departments.
• Plans, schedules, and arranges own activities and may direct others in accomplishing objectives.

Minimum Education and Basic Qualifications :

People Leader Accountabilities :

The salary range for this position is : Bay Area : $157,590.00 - $203,940.00. Other US Locations : $143,225.00 - $185,350.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.