Senior Director Regulatory Affairs
Senior Director Regulatory Affairs
GQR
Washington, United States
See who GQR has hired for this role
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!
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Seniority level
Director -
Employment type
Full-time -
Job function
Legal and Strategy/Planning -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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See who you knowFeatured Benefits
Inferred from the description for this job
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Medical insurance -
Dental insurance -
Vision insurance -
401(k) -
Paid maternity leave -
Paid paternity leave -
Disability insurance
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