Regulatory Project Manager 2 (PMO)

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.

• 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)  

• 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), <