About Alto Neuroscience, Inc. At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics. Backed by Stanford.
About the role
The 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.
What they're looking for
- 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
More about this role
Primary Role
The 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 do
Regulatory 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,...
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