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.Our Commercial organization leads our global sales and marketing strategies around the world. Our integrated team continues to solidify BioMarin's commercial presence in the United States and Europe and is rapidly growing in other regions, such as Latin America, the Middle East and Asia-Pacific.Position Summary:We are seeking a highly motivated and experienced Compassionate Use/Expanded Access (CU/EA) Program Lead to manage our global compassionate use and expanded access programs. This individual will report into Head of Integrated Evidence, Global Medical Affairs and serve as the primary liaison between internal teams, external healthcare providers, and regulatory authorities to ensure timely, ethical, and compliant access to investigational therapies and approved therapies for patients with serious or life-threatening conditions who lack other treatment options.The ideal candidate will bring strong cross-functional leadership, regulatory knowledge, and a deep commitment to patient-centered care.Key Responsibilities:Program Management: Design, implement, and manage compassionate use and expanded access strategies and programs for BioMarin products in compliance with global and country level regulatory requirements.Regulatory & Compliance Oversight: Prepare and submit required documentation to global regulatory agencies, including Expanded Access INDs, single-patient INDs, and protocol amendments.Stakeholder Engagement & Communication: Provide training and guidance to internal teams on CU/EA procedures and best practices.Strategic Development: Contribute to the development of CU/EA policies and strategies aligned with product lifecycle and global access objectives.Qualifications:Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (Advanced degree preferred).Minimum 5 years of experience in the pharmaceutical or biotechnology industry or CRO with a minimum of 5 years focused on initiation and management of expanded access programs or clinical operations.Strong understanding of global regulatory frameworks governing compassionate use and expanded access programs including country level provisions.Proven experience working with external stakeholders in a highly regulated environment.Preferred Skills and Attributes:Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience or clinical or regulatory affairs certification (e.g., RAC, SOCRA, ACRP).Familiarity with rare disease therapeutic areas a plus.Experience supporting investigational product supply logistics.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. #J-18808-Ljbffr