Associate Director, Regulatory Affairs
Core
Associate Director leading US regulatory strategy and FDA engagement for innovative medicines across the product lifecycle.
Role type
Senior IC regulatory affairs leader (US focus)
Builds
Regulatory dossiers (INDs, BLAs, NDAs) and agency interactions for innovative medicines
Domain
Biopharmaceuticals / US Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
US regulatory strategy, FDA engagement, regulatory dossier preparation, clinical development input, cross-functional leadership, regulatory landscape assessment, digital/AI tool integration
Preferred skills
PhD or PharmD, orphan drug expertise, rapidly growing pharma experience, AI-enabled regulatory tools
Technologies
AI-enabled environments, data-driven insights, digital technologies
Responsibilities
Develop and implement US regulatory strategies; Serve as primary FDA contact; Lead preparation of regulatory dossiers (INDs, BLAs, NDAs); Coordinate responses to FDA questions; Provide regulatory input into clinical study design; Monitor and interpret US regulatory changes; Partner with medical, legal, and commercial teams; Assess competitive regulatory landscape; Leverage digital/AI tools for strategy; Support strategic planning and resource allocation.
Seniority
Senior, hands-on IC with leadership responsibilities
