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Associate Director, Regulatory Strategy

Rapport Therapeutics

Boston, MA

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 4 days ago
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