Associate Director, Regulatory Strategy
Rapport Therapeutics
Rapport Therapeutics seeks an Associate Director of Regulatory Strategy to develop and execute regulatory pathways for a small-molecule neuromedicine pipeline. This Boston-based role involves cross-functional collaboration, regulatory authority engagement, and strategic guidance to advance precision therapies from development through commercialization.
Responsibilities
- Develop and implement regulatory strategies for small-molecule drug development programs
- Advise clinical, CMC, pharmacology, and nonclinical teams on regulatory requirements and implications
- Maintain regulatory applications including INDs, CTAs, and NDAs across jurisdictions
- Serve as regulatory lead on project teams and primary contact with health authorities
- Monitor global regulatory landscape and communicate potential program impacts to teams
Requirements
- Extensive regulatory affairs experience in drug development programs
- Knowledge of global regulatory requirements for INDs, CTAs, NDAs, and comparable submissions
- Experience managing regulatory applications and health authority interactions
- Strong cross-functional collaboration and stakeholder management skills
- Understanding of clinical development, chemistry/manufacturing/controls, and nonclinical strategies
- Track record identifying and mitigating regulatory risks
Vacancy posted a month ago
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