Regulatory Senior Project Manager (PMO)
Apply NowCompany: Intelliswift
Location: San Rafael, CA 94901
Description:
Job ID: 25-07272 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
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
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
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