Project Manager, Regulatory Affairs
Core
Lead delivery of regulatory affairs projects for life sciences clients, ensuring on-time, in-scope execution from initiation to completion.
Role type
Senior Project Manager, Regulatory Affairs
Builds
Regulatory project deliverables for pharmaceutical and biotechnology clients
Domain
Life Sciences / Regulatory Affairs
Deliverable
client delivery
Required skills
Project management, cross-functional team coordination, risk management, stakeholder management, regulatory process understanding, business development support
Preferred skills
Drug development lifecycle knowledge, labeling/CMC/safety domain expertise
Responsibilities
Lead regulatory projects from initiation to completion, serve as primary client contact for delivery matters, develop project plans and timelines, coordinate cross-functional teams, monitor progress and mitigate risks, ensure deliverables meet regulatory and client requirements, support proposal development, share best practices for process improvement
Seniority
Senior, hands-on IC