Associate Director, Regulatory Affairs
Core
Lead regulatory strategy and coordinate submissions for early-stage RNAi therapeutics programs to US FDA and international health agencies.
Role type
Associate Director, Regulatory Affairs Strategy
Builds
Regulatory submissions (INDs, CTAs, NDAs) and strategic guidance for Alnylam's RNAi pipeline
Domain
Biotechnology / RNAi therapeutics / Drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy definition, submission coordination, project planning, regulatory intelligence interpretation, cross-functional liaison, SOP development, stakeholder management
Preferred skills
Experience with electronic submissions, strategic thinking, team leadership
Technologies
Electronic submission systems, word processing, spreadsheets, databases
Responsibilities
Lead and define regulatory strategy for assigned programs; compile and submit regulatory documents (INDs, CTAs, NDAs); develop regulatory project plans; serve as US Regional Lead for early programs; coordinate responses to regulatory authorities; maintain regulatory files; facilitate review of technical documentation.
Seniority
Senior, hands-on IC