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.  

• 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.