Associate Director, Regulatory Affairs

Seaport Therapeutics•Boston, MA

2d•Onsite

About The Position

Seaport Therapeutics is seeking a strategic, hands-on Associate Director, Regulatory Affairs to lead regulatory project teams and submission activities across assigned development programs. The role emphasizes early development strategy, including Pre-IND/IND and Phase II proof-of-concept planning, as well as global regulatory planning for psychiatry and neurology therapies. It spans preclinical-to-clinical transitions and late-phase pathways toward approval, integrating regulatory requirements throughout the development lifecycle. The position is based in Boston’s Seaport area, with a strong preference for working onsite four days per week. The Associate Director provides strategic and operational guidance across clinical, nonclinical, CMC, and commercial functions and serves as primary regulatory lead to global project core teams. The role leads early health-authority interactions, develops risk-mitigated submissions, supports Phase II study design and Phase III readiness, and contributes to global NDA/MAA roadmaps and portfolio strategy. Success requires technical expertise, collaboration, entrepreneurial ownership, and a commitment to continuous improvement and service to patients affected by mental health conditions.

Requirements

Bachelor’s degree required; an advanced degree in a scientific discipline is preferred.
At least 7 years of global regulatory affairs experience, including early development (Pre-IND/IND) and late-phase strategy for CNS therapies.
Hands-on experience leading IND/CTA and/or NDA/MAA submissions.
Proven success leading Pre-IND or INTERACT meetings and IND/CTA submissions for psychiatry or neurology programs.
Experience designing Phase II proof-of-concept studies with validated endpoints.
Experience preparing Phase III-ready protocols and health-authority interactions, including FDA EOP2, scientific advice, and Pre-NDA interactions.
Deep knowledge of global regulatory frameworks and eCTD submission standards.
Applied fluency in FDA and EMA neuroscience guidelines and ICH standards.
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.

Nice To Haves

Proficiency with publishing and document-management tools such as Veeva, Smartsheet, and Office Timeline Pro.

Responsibilities

Provide strategic and operational regulatory guidance to internal clinical, nonclinical, CMC, and commercial teams.
Serve as the primary regulatory lead for assigned development programs and their global project core teams.
Manage regulatory timelines and document workflows to ensure submission readiness and compliance.
Lead early interactions with global health authorities, including FDA, EMA, and PMDA, on preclinical packages, first-in-human protocols, and biomarker strategies for CNS therapies.
Partner with R&D teams to embed regulatory requirements into target product profiles and investigational plans from candidate nomination through post-marketing.
Design integrated early development plans connecting preclinical toxicology, pharmacology, and CMC data with Phase I/II clinical objectives, addressing psychiatry and neurology challenges such as blood-brain barrier delivery and placebo response mitigation.
Develop risk-mitigated IND/CTA submissions.
Develop Phase II protocols, including Go/No-Go criteria and strategies to de-risk psychiatry and neurology programs.
Prepare Phase III regulatory groundwork, including End-of-Phase II meeting packages, safety database planning, and alignment with ICH guidelines for multi-regional trials.
Contribute to NDA/MAA submission roadmaps and ensure late-phase clinical, nonclinical, and CMC data packages meet regional requirements for CNS therapies.
Support portfolio prioritization by balancing early-stage innovation with late-phase assets to optimize resource allocation and regulatory success.