FSP - Sr Regulatory Program Manager
Core
Lead global regulatory strategies and execution for mRNA medicine development, registration, and post-marketing across U.S. and ex-U.S. markets.
Role type
Senior Regulatory Program Manager
Builds
Global regulatory plans, submission strategies, and governance frameworks for transformative mRNA medicines
Domain
Life Sciences / Biotechnology / mRNA therapeutics
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Global regulatory strategy, IND/BLA/MAA submissions, cross-functional stakeholder alignment, complex project management, risk mitigation, meeting facilitation, regulatory documentation (eCTD), strategic reporting
Preferred skills
Advanced degree (MS/PharmD/PhD), PMP certification, multi-modality therapeutic experience, innovation mindset
Technologies
Smartsheet, Microsoft Office Suite, One Pager, Office Timeline Pro, Veeva RIM
Responsibilities
Shape and execute forward-looking global regulatory plans; translate strategy into actionable milestones and critical paths; facilitate Global Regulatory Subteam (GRST) meetings and governance; prepare strategic dashboards and scenario plans for senior leadership; troubleshoot complex regulatory challenges; maintain meeting hygiene and action tracking
Seniority
Senior, hands-on IC with strategic leadership