Senior Manager, Regulatory Strategy
Core
Lead regulatory strategy and coordinate submissions for RNAi therapeutics to EU and international health agencies.
Role type
Senior Manager, Regulatory Strategy
Builds
Regulatory submissions (CTAs, INDs, Marketing Applications) and strategic plans for RNAi therapeutics
Domain
Biotechnology / Pharmaceuticals (RNAi therapeutics)
Deliverable
client delivery
Required skills
Regulatory strategy planning, submission authoring and coordination, regulatory intelligence distribution, project management, liaison with authorities and CROs, technical documentation review
Preferred skills
Advanced scientific degree, negotiation and influencing, strategic thinking
Technologies
Electronic submission systems, word processing, spreadsheets, databases
Responsibilities
Define regulatory strategy and lead planning/preparation/delivery of submissions; Develop detailed regulatory strategy and project plans; Serve as regulatory representative in multidisciplinary product subteams; Coordinate responses to regulatory authorities' questions; Maintain regulatory files; Facilitate review of technical regulatory documentation; Provide EU specific regulatory intelligence
Seniority
Senior Manager, strategic planning & cross-functional leadership