Enable job alerts via email!

Director, Regulatory Affairs

Seaport Therapeutics

Boston (MA)

On-site

USD 150,000 - 220,000

Full time

12 days ago

Boost your interview chances

Create a job specific, tailored resume for higher success rate.

Job summary

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.

Qualifications

  • 10+ years in global regulatory affairs, including CNS therapies.
  • Experience with IND/CTA and NDA/MAA submissions.
  • Expertise in leading Pre-IND meetings for psychiatry/neurology.

Responsibilities

  • Lead regulatory project teams and submission activities for CNS therapies.
  • Develop strategic regulatory plans from preclinical to post-marketing.
  • Oversee NDA/MAA submission roadmaps and ensure regulatory compliance.

Skills

Project Management
Regulatory Strategy
Collaboration
Communication
Attention to Detail

Education

Bachelor's degree
Advanced scientific degree

Tools

Veeva
Smartsheet
Office Timeline Pro

Job description

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.

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.
Apply for this job

*

indicates a required field

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

LinkedIn Profile

Website

Are you willing and able to work onsite in the Seaport of Boston 3-4 days per week? Select...

Get your free, confidential resume review.
or drag and drop a PDF, DOC, DOCX, ODT, or PAGES file up to 5MB.

Similar jobs

Director Regulatory Affairs

EPM Scientific

Boston

On-site

USD 200,000 - 240,000

Today
Be an early applicant

Director / Sr. Director, Regulatory Affairs CMC (Head of Regulatory CMC, Small Molecule) - Remote

Initial Therapeutics, Inc.

San Francisco

Remote

USD 160,000 - 220,000

2 days ago
Be an early applicant

Director, Regulatory Affairs

Ellsworth Adhesives

Village of Germantown

Remote

USD 110,000 - 170,000

9 days ago

Director of Regulatory Affairs

Dechra

Boston

Remote

USD 174,000 - 275,000

25 days ago

Senior Director, Regulatory Affairs Advertising & Promotion

Vertex

Boston

Remote

USD 216,000 - 324,000

28 days ago

Associate Director, Global Regulatory Project Management and Strategic Planning

Scorpion Therapeutics

Remote

USD 153,000 - 242,000

2 days ago
Be an early applicant

Director, Regulatory Affairs Advertising & Promotion (On-site or Remote)

MxD

North Chicago

Remote

USD 156,000 - 297,000

2 days ago
Be an early applicant

Director, Regulatory Affairs Advertising & Promotion (On-site or Remote)

Nuvance Health

North Chicago

Remote

USD 156,000 - 297,000

2 days ago
Be an early applicant

Director, Regulatory Affairs Advertising & Promotion (On-site or Remote)

Agnello & Rogers

North Chicago

Remote

USD 156,000 - 297,000

2 days ago
Be an early applicant