Manager Regulatory Affairs

Gilead Sciences is currently seeking a Manager, Regulatory Affairs for our site in Foster City, CA.

Responsible for the preparation of complex regulatory submissions which require interaction with departments outside of Regulatory Affairs for investigational & commercial products for assigned territories in line with ICH requirements, regional requirements & scientific & company policies & procedures. Responsible for submitting complex regulatory documents including safety reports, amendments, supplements & license renewals to clinical trial applications & marketing authorizations original INDs/CTAs & NDAs/MAAs for assigned territories. Responsible for implementing Company Core Data Sheets (CCDS) messages into local labeling for assigned products. Responsible for ensuring product packaging & associated information is updated & 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 & communicates changes in regulatory information to project teams & senior management in a timely manner. May contribute to training of staff under direction of Senior Regulatory Affairs Professional. May initiate local process improvements & contribute to local & / or global process improvements, which have an impact on the Regulatory Affairs function or other departments. Plans, schedules & arranges own activities & may direct others in accomplishing objectives. A strong commitment to teamwork is essential as we work with a variety of cross-functional teams within Gilead, including our regulatory colleagues within other international territories.