Senior Director, Corporate Counsel, Global Regulatory Affairs

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 Corporate Groups
It takes a village, and at BioMarin, our general and admin teams are the village behind our success. From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations.
Senior Director, Corporate Counsel, Global Regulatory Affairs
Job Summary
BioMarin is seeking an experienced, strategic, and business-oriented attorney to serve as the lead legal advisor to its Global Regulatory Affairs organization. This role will provide legal counsel across the full lifecycle of BioMarin's innovative therapies, from early development through global registration, commercialization, and post-approval activities.
The Senior Director, Corporate Counsel will partner closely with Regulatory Affairs, Clinical Development, Medical Affairs, Pharmacovigilance, Quality, Commercial, and other cross-functional stakeholders to support regulatory strategy and execution worldwide. The successful candidate will advise on a broad range of regulatory matters, including regulatory submissions, interactions with health authorities, product approvals, product labeling, pharmacovigilance obligations, post-marketing commitments, and evolving global regulatory requirements.
This is an exciting opportunity to join a highly collaborative Legal team dedicated to advancing transformative therapies for patients living with serious and life-threatening rare genetic diseases. The role offers the opportunity to influence critical regulatory and development decisions across multiple innovative products and therapeutic areas while serving as a trusted advisor to senior business and regulatory leaders.
Key Responsibilities
Strategic Regulatory Counseling
Serve as the primary legal advisor to BioMarin's Global Regulatory Affairs organization and provide practical, risk-based legal counsel on regulatory matters affecting investigational and approved products.
Advise Regulatory Affairs, product teams, and senior leadership regarding interactions with the U.S. Food and Drug Administration (FDA) and other global health authorities.
Partner with Regulatory Affairs leaders to develop and execute global regulatory strategies that support product development, registration, lifecycle management, and business objectives.
Anticipate and advise on regulatory risks, opportunities, and evolving legal and enforcement developments affecting BioMarin's portfolio.
Product Development, Registration, and Agency Engagement
Counsel cross-functional teams on legal and regulatory considerations throughout the product lifecycle, including early development, clinical development, marketing applications, product approvals, and post-approval activities.
Review and advise on key regulatory submissions, briefing materials, and correspondence with health authorities, including submissions supporting clinical development, marketing authorization, and post-approval changes.
Provide legal guidance in connection with meetings, inspections, inquiries, and other interactions with regulatory authorities.
Advise on expedited development and review programs, orphan drug matters, pediatric development requirements, regulatory exclusivities, and other regulatory pathways relevant to innovative medicines.
Regulatory Strategy and Product Lifecycle Management
Provide legal guidance on regulatory considerations throughout the product lifecycle, from early development through registration, commercialization, and post-approval activities.
Advise on global regulatory strategies for investigational and approved products, including lifecycle management initiatives and post-marketing commitments.
Counsel Regulatory Affairs and product teams regarding the interpretation and application of evolving regulatory requirements and agency expectations.
Partner with Regulatory Affairs leadership to identify and mitigate regulatory risks that could affect development timelines, product approvals, supply continuity, or marketed products.
Advise on the regulatory implications of business, development, and portfolio decisions across multiple products and jurisdictions.
Product Labeling
Provide strategic legal guidance on the development, negotiation, maintenance, and implementation of product labeling for investigational and approved products.
Partner with Regulatory Affairs and cross-functional stakeholders to anticipate and address legal and regulatory issues arising during labeling negotiations with health authorities.
Advise on global labeling requirements, core labeling strategy, and consistency considerations across jurisdictions.
Pharmacovigilance and Post-Marketing Compliance
Collaborate with Pharmacovigilance and Safety teams to support compliance with adverse event reporting, signal management, risk management plans, risk evaluation and mitigation strategies, and other post-marketing safety obligations.
Advise on regulatory requirements related to safety reporting, inspections, audits, investigations, and communications with health authorities.
Provide legal support for post-marketing commitments, required studies, and regulatory compliance ac

Skills
Regulatory Affairs, Negotiation, Risk Management, Pharmacovigilance, Regulatory Compliance