Regulatory Senior Project Manager (PMO)

Regulatory Senior Project Manager

Pay : $75-80 / hour

12-Month Assignment (Potential to Extend / Convert)

Location : Hybrid in San Rafael, CA

Our 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 :

Cross-functional Leadership :

Education & Experience :

Please submit your resume in Word or PDF format to be considered.

Salary : $75 - $80