Project Manager, Regulatory Affairs / Quality Assurance
Core
Strategic project management partner for Regulatory Affairs & Quality Assurance leadership, executing regulatory strategies and quality-assurance readiness across drug development programs from clinical development through marketing application submission and post-approval lifecycle.
Role type
Senior IC Regulatory Affairs & Quality Assurance Project Manager
Builds
Integrated regulatory project plans, submission pathways, content plans, review timelines, and quality-assurance readiness for New Drug Application (NDA) submissions.
Domain
Life Sciences / Pharmaceutical Regulatory Affairs & Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Regulatory strategy execution, cross-functional planning, health authority engagement, inspection readiness, GxP compliance, risk management (RAID logs), executive reporting, vendor management, budget tracking, workflow automation
Preferred skills
NDA content integration (eCTD Modules 1-5), FDA meeting coordination, Regulatory Affairs Certification (RAC), Project Management Professional (PMP), regulatory information management systems
Technologies
Smartsheet, Microsoft Office, eCTD, Coupa, Ivalua, SAP, Ariba
Responsibilities
Translate global and U.S. regulatory strategies into executable plans; develop integrated regulatory project plans for assigned programs; drive cross-functional planning for NDA submissions; coordinate regulatory deliverables across multiple functions; plan and facilitate health authority interactions; maintain regulatory RAID and decision logs; integrate Quality Assurance activities including inspection readiness; facilitate RAQA governance; develop dashboards and executive reporting; support functional budget and resource planning; coordinate external regulatory consultants and vendors.
Seniority
Senior, hands-on IC
