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About the Role
Gilead is dedicated to creating a healthier world by tackling diseases like HIV, viral hepatitis, COVID-19, and cancer. We are seeking passionate and ambitious individuals to join our team and contribute to the discovery and development of life-changing scientific innovations. As a people leader, you will be instrumental in shaping our culture and fostering an inclusive environment where employees can thrive.
Responsibilities
- Represents regional Regulatory Affairs or serves as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.
- Defines the regulatory strategy for Gilead/Kite products or projects with guidance.
- Evaluates changes to the local regulatory landscape and communicates risks and opportunities to the global study team.
- Identifies regulatory risks/issues and develops mitigation and/or contingency plans.
- Leads the preparation, compilation, and timely filing of regulatory submissions for commercial or investigational products.
- Leads cross-functional teams in authoring regulatory documents, including meeting requests and Module 1 documents for new drug submission.
- Provides input to the content of the original label and label updates.
- Ensures product packaging and associated information are updated and maintained according to the product license.
- Contributes to process improvements and special projects within Regulatory Affairs.
- Ensures own work complies with established practices, policies, processes, and regulatory requirements.
Requirements
- Must be a current Gilead employee or contractor to apply via the Internal Career Opportunities portal in Workday.
About the Company
- For more than 35 years, Gilead has worked to tackle diseases such as HIV, viral hepatitis, COVID-19 and cancer.
- We are committed to developing therapies that help improve lives and ensure access to these therapies across the globe.
- 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.
- 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, 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.