Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs

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.