Regulatory Project Manager

*W2 Only Job Title: Regulatory Senior Project Manager Location: San Rafael, CADuration: 03/03/2025 - 03/03/2026Schedule: Full-time (40 hours/week)Overview:The Regulatory Senior Project Manager will support and drive the efficiency of regulatory and cross-functional sub-teams, working closely with Global Regulatory Leads (GRLs). This role ensures seamless meeting management, timeline tracking, and cross-functional communication to align regulatory strategies with program objectives.Key Responsibilities:Project Strategy & ExecutionSupport global regulatory strategies and operations to align with program goals.Develop, manage, and track regulatory project timelines across the product lifecycle.Coordinate with cross-functional Project Managers to align regulatory timelines with broader project plans.Track global regulatory submissions, approvals, and commitments in designated systems.Prepare project dashboards highlighting key regulatory activities and milestones.Meeting Management & SupportSchedule and facilitate Global Regulatory Team (GRT) and Regulatory Advisory Board (RAB) meetings.Document meeting minutes, action items, and track completion.Provide high-level support for regulatory filings and other key regulatory meetings.Cross-Functional LeadershipAct as a liaison between regulatory teams and other departments to ensure alignment.Communicate regulatory updates and activities to internal and external stakeholders.Contribute to process improvements within Regulatory Affairs and Project Management.Qualifications:Bachelor's degree in health or life sciences; Master's or MBA preferred.8+ years of experience (6+ with a Masters/MBA), preferably in biotech or pharmaceuticals.Strong project management and regulatory knowledge with experience in drug development.Excellent communication, problem-solving, and cross-functional collaboration skills.Proficiency in tracking systems, timeline management, and regulatory processes.This position offers a dynamic opportunity to contribute to regulatory project success while driving efficiency and cross-functional alignment.

Created: 2025-02-19