Primary RoleThe Senior Director, Regulatory Strategy & Registration is a senior regulatory affairs leader responsible for developing and executing global regulatory strategy(ies) across one or more of Alto Neuroscience's development programs. This role serves as the primary regulatory point of contact (global regulatory leader/GRL) with health authorities, partners cross-functionally to shape program direction, and ensures regulatory activities are planned and executed to support efficient, on-time development from IND through approval. The ideal candidate brings deep regulatory strategy experience, a track record of successful expedited-pathway designations, and the ability to operate with sound judgment in a lean, fast-moving biotech environment.
What you'll doRegulatory Strategy- Develop and lead global regulatory strategy for assigned rare disease and/or neuroscience programs, from IND/CTA through NDA/BLA
- Serve as GRL (eg, strategist and primary liaison) for interactions with FDA, EMA, MHRA and other health authorities, including pre-IND, End-of-Phase 2, and pre-NDA/BLA meetings
- Identify, pursue, and manage expedited program designations, including Breakthrough Therapy, Fast Track, Special Protocol Assessment, RMAT, and Orphan Drug Designation
- Author and oversee development of regulatory strategy documents, briefing packages, and health authority meeting materials
- Anticipate regulatory risks and development roadblocks; advise clinical, executive, and governance leadership on regulatory strategy, development options, risk tradeoffs, and mitigation plans.
- Partner closely with Clinical Development, CMC, Biostatistics, Nonclinical, and Medical Writing to align regulatory strategy with program timelines and data packages
Submissions & Operations- Oversee planning, content, and quality of regulatory submissions, including original INDs/CTAs, amendments, annual reports, and meeting requests
- Ensure timely, accurate maintenance of regulatory submissions and correspondence within Alto's Regulatory Information Management system (KIVO)
- Coordinate with regulatory publishing partners to ensure eCTD-compliant, submission-ready deliverables
- Support inspection readiness and respond to regulatory questions arising from health authority interactions
Leadership & Cross-Functional Influence- Provide functional leadership for regulatory strategy across assigned programs, including direction and oversight of regulatory contractors/resources and mentorship of cross-functional team members.
- Represent GRS on CFTs and in governance/decision-making forums
- Provide senior regulatory perspective in business development due diligence, portfolio prioritization, and governance discussions, including assessment of regulatory risk, opportunity, and development feasibility.
- Monitor evolving global regulatory guidance and precedent relevant to neuroscience therapeutics, and translate implications into program strategy
LocationPreferred: Mountain View, CA (hybrid). Remote considered for the right candidate.
Salary Range$210,000 - $285,000
*depending on qualifications and experience levelTravel RequiredOccasional travel for health authority meetings, investigator/site engagement, and team offsites, as needed
QualificationsRequired- Advanced degree in a scientific, medical, or health-related discipline (PhD, PharmD, MD, or MS with extensive experience)
- 15+ years of progressive regulatory affairs experience in biotech or pharma, including significant experience leading global regulatory strategy and serving as regulatory lead for development programs.
- Demonstrated success leading health authority interactions and securing expedited designations
(eg, Breakthrough Therapy, Fast Track, SPA) - Direct experience as regulatory lead on IND/CTA through NDA/BLA/MAA program, multiple NDA approvals preferred
- Strong working knowledge of ICH guidelines, GCP, and global regulatory requirements
- Excellent strategic, written, and verbal communication skills with the ability to influence senior stakeholders
- Ability to operate independently and manage ambiguity in a fast-paced, resource-lean biotech environment
Bonus Skills/Abilities:- Neuroscience therapeutic area expertise directly relevant to Alto's pipeline preferred with experience in other therapeutic areas and rare disease a plus
- Experience with Regulatory Information Management systems (e.g., Veeva, KIVO) and eCTD publishing workflows
- Demonstrated ability to build, scale, or strengthen regulatory strategy capabilities, processes, and ways of working in a growth-stage or resource-lean biotech environment.
- Experience working with FDA CSS and FDA Advisory Committees also a plus
- Experience supporting business development due diligence from a regulatory perspective
Supervisory Responsibilities:
- Responsible for managing vendors supporting regulatory activities with potential for 1-2 reports
Education and Experience:- Advanced degree in a scientific, medical, or health-related discipline (PhD, PharmD, MD, or MS with extensive experience), specific specialization in Regulatory (eg, MS in RA or RAQA) a plus
- 15+ years of progressive regulatory affairs experience in biotech or pharma, including significant experience leading global regulatory strategy and serving as GRL for neuroscience development programs.
