Senior Director, Regulatory Operations

Role:

Senior Director, Regulatory Operations

Bay Area

Company Description:

This is a next-generation cell therapy biotech developing treatments for chronic autoimmune disorders. After four Investigational New Drug (IND) milestones in the past year alone, the team is expecting significant clinical activity, and an explosive hiring period across the Regulatory, Quality, CMC, and Clinical groups.

Role Description:

As the Regulatory Operations Senior Director, you will be the first within this sector of the Regulatory Affairs group. Reporting up to the Head of Global Regulatory Affairs, your role will be to establish Regulatory Operations systems, implement a new document management system, manage outside publishing vendors, and build out your own team.

Culture Description:

If you thrive in an innovative and fast-paced environment, this is the place for you. They put their money where their mouth is, their Regulatory success over the last 12 months being the prime example. Your hiring manager is a one of the most personable in the field, always bringing a smile to each and every call. They know when to have fun and know when it’s time to be serious.

Qualifications:

• Bachelor’s Degree required
• 10-12+ years in the Regulatory Operations field or a similar vertical.
• Strong knowledge of both Regulatory Operations and Regulatory Publishing
• Experience setting up and establishing a Regulatory Operations department; Leadership experience required
• Previous experience in a small company setting.