Executive Director Global Regulatory Affairs

Regulatory Connect; United States; On-site; USD 250,000 - 320,000; Full time

Job summary

Regulatory Connect is partnering with a global biotechnology company to appoint an Executive Director of Regulatory Affairs who will lead the global registration strategy for a late-stage oncology program approaching submission. This role is remote from anywhere in the US and will oversee US NDA submissions, FDA interactions, and global regulatory leadership.

The Executive Director will coordinate with regional leads across US, Europe, Japan and other markets to drive submissions, approvals and

Qualifications

• Proven leadership of an NDA and/or BLA submission, ideally through FDA approval.
• Strong experience developing late-stage regulatory strategy and engaging directly with the FDA.
• Experience leading global marketing applications and coordinating regional submissions.
• Strong cross-functional leadership within a biotechnology or pharmaceutical environment.

Skills

NDA/BLA submission

FDA engagement

global regulatory strategy

cross-functional leadership

Job description

Senior Director/Executive Director RA - Remote from anywhere in the US

Regulatory Connect is partnering with a global biotechnology company to appoint an Executive Director of Regulatory Affairs who will lead the global registration strategy for a late-stage oncology program approaching submission.

This individual will have overall regulatory leadership of the program across the US, Europe, Japan and other key markets. A primary focus will be leading the US NDA through submission, FDA review and approval, supported by regional regulatory leads managing the parallel ex-US applications.

Key experience required:

• Proven leadership of an NDA and/or BLA submission, ideally through FDA approval
• Strong experience developing late-stage regulatory strategy and engaging directly with the FDA
• Experience leading global marketing applications and coordinating regional submissions
• Strong cross-functional leadership within a biotechnology or pharmaceutical environment

This is a highly visible opportunity to take ownership of a global oncology program at a pivotal stage of development and lead it through registration, approval and commercialization.