REGULATORY SENIOR PROJECT MANAGER

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our R&D 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 rare diseases.

As part of the Global Regulatory Affairs & Patient Safety (GRAPS) department, 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.

Contribute to and support global regulatory 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)

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

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

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.

Ireland Safety Responsibility

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.