Regulatory Affairs Project Manager

Regulatory Senior Project ManagerPay: $75-80hour12-Month Assignment (Potential to Extend Convert) Location: Hybrid in San Rafael, CAOur client, a leading global biotech company dedicated to delivering innovative therapeutics for patients with serious and life-threatening rare genetic diseases, is seeking a Regulatory Sr. Project Manager to join their team. As part of the R&D Project Management Organization (PMO), the Regulatory Senior Project Manager will play a critical role in supporting and driving the efficiency and effectiveness of Regulatory or cross-functional sub-teams. This individual will work in close partnership with the Global Regulatory Lead (GRL) or team lead, providing strategic guidance through meeting management, timeline development, project tracking, and cross-functional communications.Key Responsibilities:Strategy and Execution:Support and contribute to global Regulatory Affairs strategies and operations, ensuring alignment with program goals and objectives.Track and drive action item completion to meet regulatory milestones and deliverables.Partner with GRL and functional regulatory leads to prioritize team activities and manage competing priorities.Develop, maintain, and track regulatory project timelines from the pre-clinical phase through the product lifecycle.Ensure regulatory timelines integrate with cross-functional dependencies by liaising with project managers from other functional areas.Prepare project dashboards, highlighting key regulatory activities such as submission and approval milestones.Track and monitor global regulatory submissions, approvals, and lifecycle maintenance commitments, ensuring timely updates in the designated tracking system.Enforce team charter guidelines in collaboration with the GRL.Meeting Management & Support:Schedule and facilitate Global Regulatory Team (GRT) meetings, generate agendas, and documentdistribute meeting anize and support Regulatory Advisory Board (RAB) meetings, ensuring documentation and action item follow-ups.Provide high-level support for regulatory filing teams, including MAINDCTA submissions.Document decisions and action items for additional meetings such as Advisory Committees, Paediatric Investigation Plans (PIP), and ad hoc regulatory discussions.Cross-functional Leadership:Act as a liaison across regulatory teams, sub-teams, and cross-functional filing teams to ensure alignment and clear municate regulatory updates and key activities to internal stakeholders and external partners.Partner with cross-functional teams to transition products from development to the marketed stage.Represent Regulatory Affairs on the Production Integration Management Team (PRIME) and ensure regulatory activities align with product dashboards and deliverables.Identify and implement process improvement opportunities within Regulatory Affairs and the PMO.Education & Experience:Bachelor's degree in Health or Life Sciences (e.g., Chemistry, Molecular Biology, or similar field) required; Master's degree or MBA preferred.8+ years of experience with a bachelor's degree, or 6+ years with a master'sMBA.Prior experience in project management within a Biotechnology or Pharmaceutical company preferred.Please submit your resume in Word or PDF format to be considered.

Created: 2025-02-24