Regulatory Affairs Specialist at Gilead sciences, inc.

Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.

Defines the regulatory strategy for one or more Gilead/Kite products or projects.

Evaluates changes to the local regulatory landscape and sharing risks and opportunities with the global study team when necessary.

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).

Leads cross-functional teams in the authoring of regulatory documents, including meeting requests, Module 1 documents for new drug submission, 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.

Gilead sciences, inc.

Regulatory Affairs Specialist

Role Overview

About Gilead sciences, inc.

Key Responsibilities

Requirements & Eligibility

Required Skills & Tech