Regulatory Senior Project Manager (PMO)

Are you an experienced Regulatory Senior Project Manager (PMO) with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Regulatory Senior Project Manager (PMO) to work at their company in San Rafael, CA.Position Summary: As part of the R&D Project Management Organization (PMO), this role supports and drives the efficiency and effectiveness of Regulatory or cross-functional sub-teams in partnership with the Global Regulatory Lead (GRL) or team lead through:Meeting managementTimeline development, management, and trackingCross-functional communicationsPrimary Responsibilities/Accountabilities:Strategy and ExecutionContribute to and support global Regulatory Affairs strategies and operations.Ensure alignment with program goals/objectives and input of the GRT with functional regulatory representatives.Track and drive for action item completion.Partner with GRL and functional regulatory leads to prioritize team activities and manage competing priorities.Develop regulatory project timelines in collaboration with functional regulatory leads and cross-functional stakeholders.Liaise with Project Managers in other functional areas to ensure regulatory timelines are integrated and linked.Document regulatory milestones/deliverables in the timeline(s) and report progress against goals.Prepare project and cross-project dashboards for teams/management.Track Regulatory submissions and approvals globally in the designated tracking system.Track and monitor completion of commitments for lifecycle maintenance.Enforce guidelines of GRT Charter in partnership with Global Regulatory Lead (GRL).Meeting Management & SupportSchedule GRT meetings, generate the agenda, facilitate meetings, and document/distribute minutes.Schedule Regulatory Advisory Boards (RABs), facilitate meetings, and document/distribute minutes.Provide high-level support to MA/IND/CTA Filing teams.Document decisions and/or action items for other meetings as needed.Cross-functional LeadershipLiaise across Regulatory teams, sub-teams, and cross-functional Filing Teams.Communicate regulatory information and activities to stakeholders.Partner with stakeholders to transition products from development to marketed stage.Represent Regulatory Affairs on Production Integration Management Team (PRIME).Identify and implement opportunities for process improvement within Regulatory Affairs and the PMO.Qualifications:Decision Making and Problem SolvingInfluence, Cross-Functional Collaboration and Organizational AwarenessAgility and ProactivityLeadershipCommunicationStrategic Thinking and PlanningProject ManagementTeam and Stakeholder Management and CommunicationDrug Development and Product KnowledgeRegulatory Guidances and ProcessesProcess Improvement

Created: 2025-02-19