Job Details
Senior Director Regulatory Affairs - Clinical/Nonclinical Strategy
A leading biopharmaceutical company is urgently seeking a Senior Director of Regulatory Affairs to support a high-profile program. This role is critical to the mission of bringing transformative therapies to patients with unmet medical needs.
Key Responsibilities:
- Lead regulatory strategies and plans for the development, registration, and life-cycle management of innovative rare disease programs.
- Act as the primary liaison with global regulatory agencies to expedite approvals and resolve key regulatory issues.
- Oversee the preparation and management of all regulatory documents and submissions.
- Provide strategic direction on clinical and nonclinical aspects of programs and ensure high-quality deliverables.
Qualifications:
- BA/BS in life sciences (Advanced degree preferred).
- 12+ years of experience in Regulatory Affairs within biotech or pharma.
- Proven track record in managing major submissions and interacting with regulatory authorities.
- Experience with expedited approval pathways (ODD, FTD, BTD).
- Must be based on the East Coast; remote flexibility available.
Join our team and play a pivotal role in advancing groundbreaking treatments for rare diseases. Apply now to be part of a dedicated team!