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A clinical-stage biopharmaceutical company is seeking a Director of Regulatory Affairs to lead regulatory strategies for CNS therapies. The ideal candidate will have extensive experience in global regulatory affairs, particularly in early development and late-phase strategies. This role offers an opportunity to contribute significantly to novel neuropsychiatric medicines and be part of a mission-driven team.
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph TM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visitwww.seaporttx.com .
Position Summary:
We are seeking a strategic, hands-on Director, Regulatory Affairs to lead regulatory project teams and submission activities across assigned development programs. We seek a candidate who thinks innovatively and has deep expertise in early development (Pre-IND/IND) and Phase II proof-of-concept (PoC) strategy, coupled with a strong foundation in global regulatory planning for psychiatry and neurology therapies. This role requires equal emphasis on shaping preclinical-to-clinical transitions and aligning late-phase pathways towards approval, ensuring seamless integration of regulatory requirements across the development lifecycle. The ideal candidate thrives in a collaborative environment, and is excited to contribute to a mission-driven company making a difference in neuropsychiatric care. This is an in-office role, 3-4 days per week, and reports to the VP, Regulatory Affairs.
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Are you willing and able to work onsite in the Seaport of Boston 3-4 days per week? Select...