Regulatory Senior Project Manager

DescriptionWho 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. PM responsibilities may include:Strategy and Execution 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 dependenciesDocument 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 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 GRAPSCompetencies:Decision Making and Problem SolvingInfluence, Cross-Functional Collaboration and Organizational AwarenessAgility and ProactivityLeadershipCommunication Strategic Thinking and Planning Project ManagementTeam and Stakeholder Management and Communication Drug Development and Product KnowledgeRegulatory Guidances and ProcessesProcess ImprovementEducation & Experience:Degree in health or life sciences, including chemistry, molecular biology, or similar; Masters or MBA preferred6+ years with Masters/MBA, 8+ with bachelor’s degreeProject Management in a Biotech or Pharmaceutical Company experience preferredNote: 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 ResponsibilitySupport 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.