LinkedIn Top Voice 6x💡 Vice President | GQR Life Sciences 🔍
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!
Seniority level
Director
Employment type
Full-time
Job function
Legal and Strategy/Planning
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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