Associate Director, Regulatory Affairs

The role

The Associate Director, Regulatory Affairs will lead regulatory project teams and submission activities across assigned development programs. This person will provide strategic and operational regulatory guidance to internal teams and lead early interactions with global health authorities.

What you will do

• 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 with global health authorities to secure alignment on preclinical packages, first-in-human protocols, and biomarker strategies.
• Partner with R&D teams to embed regulatory requirements into target product profiles and investigational plans.
• Design integrated early development strategic plans bridging preclinical data with Phase I/II clinical objectives.
• Craft risk-mitigated IND/CTA submissions.
• Support Phase II PoC and Phase III Readiness.
• Contribute to NDA/MAA submission roadmaps.
• Support portfolio prioritization.

Required qualifications

• Bachelor’s degree
• 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
• Success leading Pre-IND or INTERACT meetings and IND/CTA submissions for psychiatry/neurology programs
• Success designing Phase II PoC studies with validated endpoints
• Success preparing Phase III-ready protocols and health authority interactions
• 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

Nice to have

• advanced degree in a scientific discipline

About the company

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company uses its proprietary GlyphTM technology platform to advance clinically validated mechanisms.