Director, Regulatory Affairs

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 visit www.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.   

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 for day one to post marketing from candidate nomination through post-marketing. 

• Design integrated early development strategic plans that bridge preclinical data (toxicology, pharmacology, CMC) with Phase I/II clinical objectives, addressing unique psychiatry/neurology challenges (e.g., blood-brain barrier delivery, placebo response mitigation). 

• Craft risk-mitigated IND/CTA submissions 

• Support Phase II PoC & Phase III Readiness; Develop Phase II protocols with Go/No-Go criteria and strategies to de-risk psychiatry/neurology programs; Prepare Phase III regulatory groundwork, including End-of-Phase II (EOP2) meeting packages, safety database planning, and alignment with ICH guidelines for multi-regional trials. 

 

• Global Submission & Portfolio Strategy; Oversee NDA/MAA submission roadmaps, ensuring late-phase clinical, nonclinical and CMC data packages meet regional requirements for CNS therapies; Advise on portfolio prioritization, balancing early-stage innovation (Pre-IND/IND) with late-phase assets to optimize resource allocation and regulatory success. 

 

Qualifications: 

• Bachelor’s degree required; advanced degree in a scientific discipline preferred. 

•  10+ years in global regulatory affairs with including expertise in early development (Pre-IND/IND) and late-phase strategy for CNS therapies. 

• Relevant hands-on experience leading IND/CTA and/or NDA/MAA submissions. 

• Proven success in: 

• Leading Pre-IND or INTERACT meetings and IND/CTA submissions for psychiatry/neurology programs. 

• Designing Phase II PoC studies with validated endpoints  

• Preparing Phase III-ready protocols and health authority interactions (FDA EOP2, scientific advice, PNDA). 

• Deep knowledge of global regulatory frameworks and eCTD submission standards. 

• Practical applied Fluency in FDA/EMA neuroscience guidelines and ICH standards. 

• Proficiency with publishing and document management tools (e.g., Veeva, Smartsheet, office timeline pro) 

• Strong project management skills and a track record of driving regulatory deliverables in a fast-paced environment. 

• Exceptional attention to detail, collaboration, and communication skills.