Associate Director, CNS Regulatory Strategy

Seaport Therapeutics; Boston (MA); On-site; USD 180,000 - 205,000; Full time

Job summary

Seaport Therapeutics is seeking an Associate Director, Regulatory Affairs in Boston to lead regulatory project teams across early and late development programs for CNS therapies. You will oversee global planning, interact with FDA/EMA/PMDA, and ensure integration of regulatory requirements from preclinical through Phase III readiness.

The role emphasizes hands-on leadership, cross-functional collaboration, and a strong track record in IND/CTA and NDA/MAA submissions, with onsite work four days

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 7+ years in global regulatory affairs with CNS experience.
• Experience leading IND/CTA and NDA/MAA submissions.
• Proven success in Pre-IND/INTERACT meetings and regulatory strategy.

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 with global health authorities (FDA, EMA, PMDA) for CNS therapies.
• Design integrated early development strategic plans bridging preclinical data with Phase I/II objectives.
• Craft risk-mitigated IND/CTA submissions.
• Support Phase II PoC & Phase III Readiness; develop Phase II protocols and regulatory groundwork.
• Contribute to NDA/MAA submission roadmaps and portfolio strategy like balancing early and late‑phase assets.

Skills

Regulatory strategy

Pre-IND/IND

NDA/MAA submissions

Health authority liaison

Global regulatory planning

Project management

Documentation management

Cross-functional leadership

Education

Bachelor’s degree

Advanced degree in science

Tools

Veeva

Smartsheet

Office Timeline Pro

Job description

Seaport Therapeutics is seeking an Associate Director, Regulatory Affairs in Boston to lead regulatory project teams across early and late development programs for CNS therapies. You will oversee global planning, interact with FDA/EMA/PMDA, and ensure integration of regulatory requirements from preclinical through Phase III readiness.

The role emphasizes hands-on leadership, cross-functional collaboration, and a strong track record in IND/CTA and NDA/MAA submissions, with onsite work four days