Regulatory Senior Project Manager

BioMarin Pharmaceutical•San Rafael, CA

About The Position

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Our revolutionary treatments for conditions like achondroplasia, PKU, CLN2, and various forms of MPS offer new possibilities for patients and families. With the recent acquisition of Amicus, our portfolio now includes therapies for Fabry disease and Pompe disease. Our success is driven by our commitment to excellence, understanding of patient needs, scientific expertise, and manufacturing capabilities. The Worldwide Research and Development organization, specifically the Global Regulatory Affairs & Patient Safety (GRAPS) department, is seeking a Regulatory Senior Project Manager. This role 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. Responsibilities include meeting management, timeline development/management/tracking, and cross-functional communications.

Requirements

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

Nice To Haves

Masters or MBA preferred

Responsibilities

Contribute to and support global regulatory strategies and operations, ensuring alignment 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).
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.
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 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 GRAPS.
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems.
Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.