Global Therapeutic Area Lead

3 days ago


Uxbridge, United Kingdom Gilead Sciences, Inc. Full time
Job Title: Global Therapeutic Area Lead

Gilead Sciences, Inc. is a leading biopharmaceutical company committed to creating a healthier world for all people. With over 35 years of experience, we've developed therapies that help improve lives and ensure access to these therapies across the globe. We're currently seeking a highly skilled Global Therapeutic Area Lead to join our team.

About the Role:
In this role, you will work within the global team and closely with local teams to define the regulatory strategy, plans, and objectives for assigned products or projects. You will manage regulatory submissions and other projects, representing the IC/GPS regulatory franchise on cross-functional core and sub-teams.

Key Responsibilities:
- Manage and lead regulatory strategies for designated products in the region, including new product licenses and lifecycle activities.
- Prepare and maintain regulatory submissions, regulatory labeling, and packaging for assigned products or projects.
- Collaborate with cross-functional partners to ensure optimal execution of the agreed regulatory strategy.

Requirements:
- BA/BS or advanced degree in life sciences or related field with regulatory experience in the biopharma industry, regulatory agency, clinical research, or other related healthcare environment.
- Good working knowledge of ICH and regional requirements, as well as current global and regional trends in Regulatory Affairs.

Salary: £60,000 - £80,000 per annum, depending on experience.

Location: Stockley Park or Cambridge office.

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