FSP - Sr Regulatory Program Manager - client dedicated
Core
Senior regulatory program manager leading global regulatory strategies, plans, and execution for mRNA medicine development and registration across U.S. and ex-U.S. markets.
Role type
Senior IC regulatory program manager
Builds
Global regulatory plans, submission strategies, and governance frameworks for mRNA therapeutics
Domain
Life Sciences / Biotechnology / mRNA
Required skills
Global regulatory strategy, project management, stakeholder alignment, risk management, meeting facilitation, regulatory documentation, eCTD, cross-functional collaboration
Preferred skills
Advanced degree (MS/PharmD/PhD), PMP certification, multi-modality therapeutic experience, innovative regulatory pathway design
Technologies
Smartsheet, Microsoft Office Suite, One Pager, Office Timeline Pro, Veeva RIM
Responsibilities
Shape and execute global regulatory plans across development and post-marketing stages; facilitate Global Regulatory Subteam (GRST) meetings and forums; translate strategy into actionable plans with milestones and risk assessments; prepare strategic dashboards and reports for senior leadership; manage complex regulatory deliverables and timelines; troubleshoot operational challenges and implement scalable solutions.
Seniority
Senior, hands-on IC