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

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Vacancy posted 8 days ago

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