Global Regulatory Strategy Director
Core
Shape and lead regulatory strategies for an innovative pipeline of first-in-class small-molecule medicines, guiding global project teams from Phase 2 through registration and lifecycle management.
Role type
Senior Director, Global Regulatory Strategy
Builds
Global development and registration plans for clinical-stage small-molecule medicines
Domain
Biotechnology / Pharmaceutical Regulatory Affairs
Required skills
Global regulatory strategy, IND/CTx/NDA/DMF/IMPD submissions, FDA/EMA/Health Canada interactions, regulatory risk mitigation, team leadership, AI integration in dossier development, cross-functional collaboration
Preferred skills
Obesity or dermatology program experience, advanced degree (MS/PharmD/PhD)
Technologies
AI tools for dossier preparation
Responsibilities
Establish global regulatory and registrational strategies for clinical-stage assets; Lead preparation and submission of regulatory documentation (INDs, CTx, NDAs, DMFs, IMPDs); Represent the organization in negotiations with global health authorities; Identify regulatory gaps and develop mitigation strategies; Lead and mentor global regulatory teams; Monitor changes in global regulatory requirements and communicate impact to senior leadership; Guide cross-functional teams in adopting AI-enabled approaches for regulatory dossier preparation.
Seniority
Director, strategic leadership with hands-on execution