Job Description
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research And Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
As part of the BioMarin 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
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 & Experience: - Degree in health or life sciences, including chemistry, molecular biology, or similar; Masters or MBA preferred
- 6+ years with Masters/MBA, 8+ with bachelor’s degree
- Project Management in a Biotech or Pharmaceutical Company experience preferred
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Job Tags
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