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.
Specific Education & Experience Requirements:
12+ years of experience in Regulatory Affairs or other relevant industry experience
Degree in a scientific field is preferred.
Specific Job Responsibilities:
Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance is met for assigned product(s) and territories.
Prepare and/or manage others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
Responsible for ensuring preparation of the Product Company Core Data Sheets (CCDS), regulatory review of draft Product Company Co