---
title: 'Associate Director, Regulatory Affairs at Seaport Therapeutics'
canonical: 'https://feeny.ai/job/associate-director-regulatory-affairs-seaport-therapeutics-boston-53hk1e3k4n8x'
type: 'job'
last_seen: '2026-11-01'
---

# Associate Director, Regulatory Affairs at Seaport Therapeutics

- **Company:** Seaport Therapeutics
- **Location:** Boston, MA
- **Posted:** 2026-10-13
- **Last confirmed live:** 2026-11-01
- **Apply:** https://job-boards.greenhouse.io/seaporttherapeutics/jobs/5451600008

## Job description

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](https://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.
- 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; Contribute to NDA/MAA submission roadmaps, ensuring late-phase clinical, nonclinical and CMC data packages meet regional requirements for CNS therapies; Support 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.
- 7+ years in global regulatory affairs, 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, Pre-NDA).
- 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.

At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $180,00-$205,000 with the final offer based on experience, market data, and internal equity. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

## About Seaport Therapeutics

## Company Overview
- **One-liner**: Seaport Therapeutics is a clinical-stage biotech company developing novel oral prodrugs for depression and anxiety using its proprietary Glyph™ platform to overcome bioavailability and side effect limitations.
- **Entity Type**: Private (clinical-stage; raised $340M in funding across Series A, Series B, and a government grant)
- **Headquarters**: Boston, Massachusetts, United States
- **Founded**: Not publicly available (the company launched as a PureTech Health-founded entity around 2023–2024, based on Series A timing)
- **Founders**: Daphne Zohar (CEO), Michael C. Chen (Co-founder, Chief Scientific Officer); the Glyph platform was co-invented by Jamie Simpson and Dan Bonner of Monash University, who are now part of the team.

## Core Business
- **Primary industry**: Biotechnology / Neuropsychiatric Drug Development
- **Target customers**: Patients with major depressive disorder, generalized anxiety disorder, and other neuropsychiatric conditions; partners and prescribers in psychiatry/neurology
- **Mission or purpose statement**: “Unlocking Better Days™” – developing new medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders.

## Products & Services
- **Glyph™ Platform**: A proprietary oral prodrug technology that enables more medicine to reach the bloodstream and brain while avoiding first-pass liver metabolism and reducing side effects like hepatotoxicity. The platform is licensed exclusively from Monash University.
- **GlyphAgo™ (SPT-320)**: Oral prodrug of agomelatine for Generalized Anxiety Disorder (GAD); Phase 1 proof-of-concept data reported in June 2026 show positive multiple-ascending dose results.
- **GlyphAllo™ (SPT-300)**: Oral prodrug of allopregnanolone for Major Depressive Disorder (MDD); designed to overcome low oral bioavailability and avoid side effects like sexual dysfunction and weight gain.
- **Glyph2BLSD™ (SPT-348)**: Oral prodrug of 2-bromo-LSD, a non-hallucinogenic neuroplastogen for multiple indications including treatment-resistant depression, PTSD, and headache disorders; preclinical stage.

## Market Standing
- **Valuation/Market Cap**: Not disclosed
- **Key Metric**: **Total Funding** – $340M as of March 2026
- **Notable Investors/Partners**:
  - Series A (April 2024): $100M led by Sofinnova Investments and ARCH Venture Partners
  - Series B (October 2024): $225M led by General Atlantic
  - Grant (March 2026): $15M from ARPA-H
  - Corporate round (January 2024): undisclosed investor
  - Strategic collaboration with Monash University (exclusive license for Glyph platform)
- **Growth Signals**:
  - Headcount grew **46.8% YoY** (from ~30 to 52 employees)
  - Positive Phase 1 proof-of-concept data for GlyphAgo (June 2026)
  - Active job postings (5 open roles as of mid-2026)
  - Strong talent inflow from PureTech Health, Karuna Therapeutics, and Bristol Myers Squibb

## Competitive Advantages
- **Proprietary Glyph™ platform** that clinically validates mechanisms previously limited by poor oral bioavailability or liver toxicity (e.g., allopregnanolone, agomelatine, 2-bromo-LSD)
- **Experienced leadership** with deep history in neuropsychiatric drug development (PureTech Health founders, Karuna veterans)
- **First/best-in-class potential** for each pipeline candidate, enabling a pipeline of multiple assets from a single validated platform
- **Worldwide exclusive license** to Monash University’s intellectual property, creating a strong IP moat

## Strategic Focus
- Advance GlyphAgo into Phase 2 trials for GAD
- Progress GlyphAllo and Glyph2BLSD through Phase 1 and toward proof-of-concept
- Expand the pipeline into additional neuropsychiatric indications (TRD, PTSD, headache disorders)
- Continue hiring across clinical development, CMC, biometrics, and program leadership roles

## Why Work Here
- **Mission-driven culture**: Focus on “Unlocking Better Days” for patients with serious mental health conditions
- **Location**: Boston Seaport district (101 Seaport, Boston, MA) – a hub for biotech innovation
- **Growth trajectory**: ~50% headcount growth in the past year signals a rapidly scaling organization with advancement opportunities
- **Team composition**: Small but experienced team (52 employees) with a high ratio of directors/managers (29% director-level), offering exposure to senior leadership
- **Flexibility**: Hybrid/office policy not explicitly stated, but the company has a physical office and lists in-person roles; likely offers flexibility typical of Boston biotechs
- **Culture highlights**: Featured office tour with CEO Daphne Zohar, an emphasis on collaboration and scientific excellence, and strong ties to PureTech Health’s entrepreneurial ecosystem

## Sources
1. [seaporttx.com](https://seaporttx.com/)
2. [seaporttx.com/our-pipeline/](https://seaporttx.com/our-pipeline/)
3. [seaporttx.com/careers/](https://seaporttx.com/careers/)
4. [LinkedIn – Seaport Therapeutics](https://www.linkedin.com/company/seaport-therapeutics)
5. [job-boards.greenhouse.io/seaporttherapeutics](http://job-boards.greenhouse.io/seaporttherapeutics)

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