Senior Director, Corporate Counsel, Global Regulatory Affairs

<p>Who We Are <br /><br />BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.<br /><br />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.<br /><br />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. <br /><br />About Corporate Groups <br /><br />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.</p><div><div><p><span><span>Senior Director, Corporate Counsel, Global Regulatory Affairs - HYBRID IN SAN RAFAEL CA OR REMOTE IN WASHINGTON DC</span></span></p></div><div><p><span><span>Job Summary</span></span></p></div><div><p><span><span>BioMarin is </span><span>seeking</span><span> 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.</span></span></p></div><div><p><span><span>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.</span></span></p></div><div><p><span><span>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.</span></span></p></div><div><p><span><span>Key Responsibilities</span></span></p></div><div><p><span><span>Strategic Regulatory Counseling</span></span></p></div><div><ul><li><p><span><span>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.</span></span></p></li></ul></div><div><ul><li><p><span><span>Advise</span><span> Regulatory Affairs, product teams, and senior leadership </span><span>regarding</span><span> interactions with the U.S. Food and Drug Administration (FDA) and other global health authorities.</span></span></p></li></ul></div><div><ul><li><p><span><span>Partner with Regulatory Affairs leaders to develop and execute global regulatory strategies that support product development, registration, lifecycle management, and business </span><span>objectives</span><span>.</span></span></p></li></ul></div><div><ul><li><p><span><span>Anticipate and advise on regulatory risks, opportunities, and evolving legal and enforcement developments affecting BioMarin's portfolio.</span></span></p></li></ul></div><div><p><span><span>Product Development, Registration, and Agency Engagement</span></span></p></div><div><ul><li><p><span><span>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.</span></span></p></li></ul></div><div><ul><li><p><span><span>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.</span></span></p></li></ul></div><div><ul><li><p><span><span>Provide</span><span> legal guidance in connection with meetings, inspections, inquiries, and other interactions with regulatory authorities.</span></span></p></li></ul></div><div><ul><li><p><span><span>Advise on</span><span> expedited development and review programs, orphan drug matters, pediatric development requirements, regulatory exclusivities, and other regulatory pathways relevant to innovative medicines.</span></span></p></li></ul></div><div><p><span><span>Regulatory Strategy and Product Lifecycle Management</span></span></p></div><div><ul><li><p><span><span>Provide</span><span> legal guidance on regulatory considerations throughout the product lifecycle, from early development through registration, commercialization, and post-approval activities.</span></span></p></li></ul></div><div><ul><li><p><span><span>Advise on</span><span> global regulatory strategies for investigational and approved products, including lifecycle management initiatives and post-marketing commitments.</span></span></p></li><li><p><span></span><span><span>Counsel Regulatory Affairs and product teams </span><span>regarding</span><span> the interpretation and application of evolving regulatory requirements and agency expectations.</span></span></p></li></ul></div></div><div><div><ul><li><p><span><span>Partner with Regulatory Affairs leadership to </span><span>identify</span><span> and mitigate regulatory risks that could affect development timelines, product approvals, supply continuity, or marketed products.</span></span></p></li></ul></div><div><ul><li><p><span><span>Advise on</span><span> the regulatory implications of business, development, and portfolio decisions across multiple products and </span><span>jurisdictions</span><span>.</span></span></p></li></ul></div><div><p><span><span>Product Labeling</span></span></p></div><div><ul><li><p><span><span>Provide</span><span> strategic legal guidance on the development, negotiation, maintenance, and implementation of product labeling for investigational and approved products.</span></span></p></li></ul></div><div><ul><li><p><span><span>Partner with Regulatory Affairs and cross-functional stakeholders to </span><span>anticipate</span><span> and address legal and regulatory issues arising during labeling negotiations with health authorities.</span></span></p></li></ul></div><div><ul><li><p><span><span>Advise on</span><span> global labeling requirements, core labeling strategy, and consistency considerations across </span><span>jurisdictions</span><span>.</span></span></p></li></ul></div><div><p><span><span>Pharmacovigilance and Post-Marketing Compliance</span></span></p><p><span><span>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.</span></span></p></div><div><ul><li><p><span><span>Advise on</span><span> regulatory requirements related to safety reporting, inspections, audits, investigations, and communications with health authorities.</span></span></p></li></ul></div><div><ul><li><p><span><span>Provide legal support for post-marketing commitments, </span><span>required</span><span> studies, and regulatory compliance activities involving approved products.</span></span></p></li><li><p><span></span><span><span>Cross-Functional Leadership</span></span></p></li></ul></div><div><ul><li><p><span><span>Collaborate closely with Legal, Compliance, Quality, Clinical Development, Medical Affairs, Commercial, Government Affairs, and other stakeholders to provide coordinated legal support.</span></span></p></li></ul></div><div><ul><li><p><span><span>Translate complex legal and regulatory requirements into clear, practical guidance for senior leaders and cross-functional teams.</span></span></p></li></ul></div><div><ul><li><p><span><span>Monitor significant regulatory and enforcement developments and provide </span><span>timely</span><span>, actionable advice </span><span>regarding</span><span> their potential impact on BioMarin's pipeline and marketed products.</span></span></p></li></ul></div><div><ul><li><p><span><span>Develop and deliver training, policies, and practical resources to strengthen regulatory compliance and organizational capabilities.</span></span></p></li></ul></div><div><ul><li><p><span><span>Manage outside counsel and contribute to Legal Department initiatives, process improvements, knowledge sharing, and team development.</span></span></p></li></ul></div><div><p><span><span>Qualifications and Professional Experience</span></span></p></div><div><p><span><span>Required</span></span></p></div><div><ul><li><p><span><span>Juris Doctor (J.D.) degree from an accredited law school and active membership in at least one U.S. state bar; eligibility for California registered in-house counsel status, if applicable.</span></span></p></li></ul></div><div><ul><li><p><span><span>Minimum of 12 years of post-J.D. legal experience, including </span><span>significant experience</span><span> advising on pharmaceutical, biotechnology, biologics, or life sciences regulatory matters.</span></span></p></li></ul></div></div><div><div><ul><li><p><span><span>Deep knowledge of U.S. FDA requirements governing drug or biologic development, approval, labeling, pharmacovigilance, and post-marketing activities.</span></span></p></li></ul></div><div><ul><li><p><span><span>Significant experience</span><span> advising on regulatory submissions, agency interactions, product development strategy, regulatory compliance, and lifecycle management.</span></span></p></li></ul></div><div><ul><li><p><span><span>Strong business acumen and </span><span>demonstrated</span><span> ability to provide practical, strategic, and risk-based legal advice in a complex and highly regulated environment.</span></span></p></li></ul></div><div><ul><li><p><span><span>Exceptional written and verbal communication skills, sound judgment, and the ability to influence senior leaders and cross-functional stakeholders.</span></span></p></li></ul></div><div><ul><li><p><span><span>Excellent analytical, organizational, and problem-solving skills, with the ability to manage multiple sophisticated matters and competing priorities.</span></span></p></li></ul></div><div><p><span><span>Preferred</span></span></p></div><div><ul><li><p><span><span>Prior experience working at or directly with the FDA strongly preferred.</span></span></p></li></ul></div><div><ul><li><p><span><span>Significant in-house experience supporting a Global Regulatory Affairs organization within a biotechnology or pharmaceutical company.</span></span></p></li></ul></div><div><ul><li><p><span><span>Experience advising on global regulatory matters involving major international health authorities.</span></span></p></li></ul></div><div><ul><li><p><span><span>Experience supporting rare disease, specialty medicine, biologic, gene therapy, or other innovative therapeutic programs.</span></span></p></li></ul></div><div><ul><li><p><span><span>Experience advising across multiple products, therapeutic areas, and stages of development.</span></span></p></li></ul></div><div><p><span><span>Leadership Competencies</span></span></p></div><div><ul><li><p><span><span>Strategic thinker with strong business judgment and regulatory </span><span>risk-assessment</span><span> skills.</span></span></p></li></ul></div><div><ul><li><p><span><span>Collaborative, pragmatic, and </span><span>solutions</span><span>-oriented approach.</span></span></p></li></ul></div><div><ul><li><p><span><span>Ability to translate complex regulatory requirements into practical business guidance.</span></span></p></li></ul></div><div><ul><li><p><span><span>Strong executive presence and ability to build trusted relationships with senior leaders.</span></span></p></li></ul></div><div><ul><li><p><span><span>Demonstrated commitment to integrity, patient focus, and BioMarin's values.</span></span></p></li></ul></div><div><p><span><span>Location</span></span></p><p><span><span>Ability to work onsite at BioMarin headquarters in San Rafael, California at least three days per week strongly preferred. Remote in Washington DC will also be considered.</span></span></p></div></div><div> </div><p><br />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. <br /><br />Equal Opportunity Employer/Veterans/Disabled <br /><br />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. <br /><br />Ireland Safety Responsibility<br />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.</p>