What are the responsibilities and job description for the Senior Director, Global Regulatory Affairs position at Barrington James?
About the Company
I’m partnering with a rapidly growing biotech developing a pipeline of cutting-edge therapies in neurology and rare neurological disorders. With strong backing and an expanding global footprint, the company is dedicated to advancing innovative science and delivering transformative treatments to patients with limited or no existing options.
Key Responsibilities
- Define and drive global regulatory strategy for neurology programs across development, registration, and post-approval.
- Collaborate with R&D, clinical, medical, and commercial teams to ensure regulatory strategies support scientific and business objectives.
- Lead the preparation, review, and submission of regulatory documents, including INDs/CTAs, protocols, investigator brochures, safety reports, and global dossiers.
- Serve as the senior regulatory point of contact with FDA, EMA, and other health authorities for neurology programs, overseeing critical interactions, briefing packages, and negotiations.
- Provide subject-matter expertise on neurology-specific regulatory requirements (e.g., endpoints, biomarkers, CNS clinical trial design, orphan/rare frameworks).
- Mentor and guide regulatory affairs team members, building leadership capability within the function.
What We’re Looking For
- 10 years of regulatory affairs experience in biotech, with deep expertise in neurology (neurodegenerative, neuroinflammatory, neuromuscular, or rare neurological conditions).
- Proven success leading global regulatory strategies and major submissions (INDs, CTAs, NDAs, BLAs, MAAs) in neurology or related areas.
- Advanced degree in life sciences (PhD, PharmD, MD, or MSc strongly preferred).
- Strong knowledge of expedited regulatory pathways (Fast Track, Breakthrough, PRIME, orphan designations) relevant to neurology and rare diseases.
- Extensive experience engaging with health authorities worldwide (FDA, EMA, PMDA, etc.).
- A strategic thinker who thrives in a dynamic, innovative biotech environment, balancing high-level leadership with hands-on involvement.
