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Regulatory Senior Project Manager (PMO)
770 Lindaro Street San Rafael, CA 94901 US
Job Description
As part of the 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
Education & Experience:
- Degree in health or life sciences, including chemistry, molecular biology, or similar; Masters Degree or MBA preferred
- 6+ years with Masters/MBA, 8+ with bachelor’s degree
- Project Management in a Biotech or Pharmaceutical Company experience preferred
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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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