Regulatory Senior Project Manager

Title: Regulatory Senior Project Manager (PMO)

Duration: 12 Months

Location: Remote (California)

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Duties:

As part of the Client’s R&D Project Management Organization (PMO), the Regulatory Senior Project Manager 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 management, timeline development / management / tracking, and cross-functional communications.

PM responsibilities may include:

Strategy and Execution

• Contribute to and support global Regulatory Affairs strategies and operations, ensuring that they align 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; maintain timelines from pre-clinical phase through product life cycle
• Liaise with Project Managers in other functional areas to ensure regulatory timelines are integrated and linked to reflect cross functional dependencies
• Document regulatory milestones/deliverables in the timeline(s) and report progress against team, department and corporate goals as needed
• Prepare project and cross-project dashboards for teams/management, highlighting key regulatory activity such as submission and approval milestones, review periods, etc.
• Track Regulatory submissions and approvals globally in the designated tracking system, if applicable for product
• Track and monitor completion of commitments for duration of lifecycle maintenance and ensure timely status updates are made in the designated tracking system, if applicable for product
• In partnership with Global Regulatory Lead (GRL), enforce guidelines of GRT Charter (or other relevant team charters)

Meeting Management & Support

• Schedule GRT meetings, generate the agenda and facilitate the meeting (in collaboration with the GRL), and document/distribute minutes (including action items) according to GRT Meeting Best Practices
• Schedule Regulatory Advisory Boards (RABs), facilitate the meeting (in collaboration with the GRL) and document/distribute minutes (including action items) according to RAB Charter
• Provide high-level support to MA/IND/CTA Filing teams (and module teams as applicable)
• For all other meetings (such as Advisory Committee, Paediatric Investigation Plan (PIP), or ad hoc), PM may document decisions and/or action items as needed

Cross-functional Leadership

• Liaise across Regulatory teams, sub-teams, and cross-functional Filing Teams to ensure consistent communication and alignment
• Communicate regulatory information and activities to stakeholders outside of regulatory and externally
• Partner with various stakeholders to transition products from development to marketed stage
• Represent Regulatory Affairs on Production Integration Management Team (PRIME) and align on deliverables/timeline with cross-functional PMs; provide input on Regulatory activities in the product dashboards created by the PRIME teams
• Identify and implement opportunities for process improvement within Regulatory Affairs and the PMO

Skills: Competencies:

• Decision Making and Problem Solving
• Influence, Cross-Functional Collaboration and Organizational Awareness
• Agility and Proactivity
• Leadership
• Communication
• Strategic Thinking and Planning
• Project Management
• Team and Stakeholder Management and Communication
• Drug Development and Product Knowledge
• Regulatory Guidances and Processes
• Process Improvement

Education:

Education & Experience:

• Degree in health or life sciences, including chemistry, molecular biology, or similar; Master’s degree or MBA preferred
• 6+ years with Masters/MBA, 8+ with bachelor’s degree
• Project Management in a Biotech or Pharmaceutical Company experience preferred