Director, Regulatory Affairs

Seaport; Boston (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

A leading biotechnology company in Boston seeks a strategic Director of Regulatory Affairs to lead regulatory project teams and ensure compliance for psychiatric and neurological medicines. The role demands extensive experience with regulatory submissions and project management within global regulatory frameworks.

Qualifications

• 10+ years in global regulatory affairs, especially in CNS therapies.
• Hands-on experience with IND/CTA and NDA/MAA submissions.
• Deep knowledge of global regulatory frameworks and FDA/EMA guidelines.

Responsibilities

• Provide strategic regulatory guidance across clinical and commercial functions.
• Manage timelines and document workflows for submissions.
• Oversee NDA/MAA submission roadmaps and advise on portfolio prioritization.

Skills

Project Management

Communication

Education

Bachelor’s degree

Advanced degree

Tools

Veeva

Smartsheet

Job description

Join to apply for the Director, Regulatory Affairs role at Seaport Therapeutics

Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The company leverages its proprietary GlyphTM technology platform to develop first-in-class medicines with improved bioavailability and reduced side effects. Led by an experienced team and guided by a network of renowned scientists and clinicians, Seaport is committed to making a difference in neuropsychiatric care. For more information, 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 development programs. The ideal candidate will have expertise in early development (Pre-IND/IND) and Phase II strategy, with a focus on psychiatry and neurology therapies. This role involves shaping preclinical-to-clinical transitions and aligning late-phase pathways towards approval, ensuring regulatory compliance throughout the development lifecycle. The position reports to the VP, Regulatory Affairs, and is based in-office 3-4 days per week.

Key Responsibilities

1. Provide strategic regulatory guidance across clinical, nonclinical, CMC, and commercial functions.
2. Lead regulatory efforts on assigned development programs.
3. Manage timelines and document workflows for submissions.
4. Lead early interactions with health authorities (FDA, EMA, PMDA).
5. Partner with R&D teams to embed regulatory requirements into development plans.
6. Design integrated development strategies addressing psychiatry/neurology challenges.
7. Prepare IND/CTA submissions with risk mitigation strategies.
8. Support Phase II PoC and Phase III readiness activities.
9. Oversee NDA/MAA submission roadmaps and advise on portfolio prioritization.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 10+ years in global regulatory affairs, with experience in CNS therapies.
• Hands-on experience with IND/CTA and NDA/MAA submissions.
• Proven success in regulatory meetings and submission preparations.
• Deep knowledge of global regulatory frameworks and standards.
• Fluency in FDA/EMA neuroscience guidelines and ICH standards.
• Proficiency with regulatory tools (e.g., Veeva, Smartsheet).
• Strong project management and communication skills.

Additional Details

• Seniority level: Director
• Employment type: Full-time
• Job function: Legal

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