Associate Director, Regulatory Affairs
Core
Lead regulatory strategy and facilitate submission of data packages to the US for early/mid/late-stage CNS programs.
Role type
Associate Director, Regulatory Affairs Strategy
Builds
Regulatory submissions (INDs, Marketing Applications, Pediatric Plans, Orphan Designation, Expedited Pathway Applications) for RNAi therapeutics
Domain
Biotechnology / Pharmaceuticals / RNAi therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy planning, US FDA interaction leadership, regulatory document compilation, project management, regulatory intelligence interpretation, SOP development, liaison with CROs and Health Authorities
Preferred skills
Strategic thinking, issue identification and mitigation, cross-functional team collaboration
Technologies
Word processing, spreadsheets, databases, online research tools
Responsibilities
Lead and define regulatory strategy for CNS programs; compile and submit regulatory documents; develop detailed regulatory project plans; coordinate responses to regulatory authorities; maintain regulatory files; facilitate review of technical regulatory documentation; provide EU specific regulatory intelligence
Seniority
Senior, hands-on IC