Regulatory Affairs

Associate Director, Regulatory Affairs

Seaport Therapeutics is a clinical-stage therapeutics 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 GlyphTM 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 visit www.seaporttx.com.

The Role
We are seeking a strategic, hands-on Associate 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 will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a “we own it” mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston’s Seaport area, with a strong preference for being onsite 4 days per week.

Key Responsibilities: 

• Provide strategic and operational regulatory guidance to internal teams across clinical, nonclinical, CMC, and commercial functions. 
• Serve as the primary regulatory lead on assigned development programs to the global project core team. 
• Responsible for regulatory timelines and document workflows to ensure submission readiness and compliance. 
• Lead early interactions (Pre-IND) with global health authorities (FDA, EMA, PMDA) to secure alignment on preclinical packages, first-in-human protocols, and biomarker strategies for CNS therapies. 
• Cross-Functional Leadership; Partner with R&D teams to embed regulatory requirements into target product profiles (TPPs) and investigational plans from candidate nomination through post-marketing.