Senior Director, Corporate Counsel, Global Regulatory Affairs

BioMarin Pharmaceutical•San Rafael, CA

21h•Hybrid

About The Position

BioMarin is seeking an experienced, strategic, and business-oriented attorney to serve as lead legal advisor to its Global Regulatory Affairs organization. The Senior Director will provide legal counsel across the lifecycle of BioMarin’s innovative therapies, from early development through global registration, commercialization, and post-approval activities. The role partners with Regulatory Affairs, Clinical Development, Medical Affairs, Pharmacovigilance, Quality, Commercial, and other cross-functional stakeholders to support regulatory strategy and execution worldwide. The attorney will advise on regulatory submissions, health authority interactions, product approvals and labeling, pharmacovigilance obligations, post-marketing commitments, and evolving global regulatory requirements. The role offers the opportunity to influence regulatory and development decisions across multiple products and therapeutic areas while serving as a trusted advisor to senior business and regulatory leaders. The position is hybrid in San Rafael, California, or remote in Washington, DC. Working onsite at BioMarin headquarters in San Rafael at least three days per week is strongly preferred. The role may include duties beyond those described. The posting also includes a safety responsibility to support environmental protection, injury prevention, and continual improvement of EHS management systems by identifying hazards, reporting incidents, and participating in EHS initiatives and training.

Requirements

Juris Doctor (J.D.) degree from an accredited law school.
Active membership in at least one U.S. state bar; eligibility for California registered in-house counsel status, if applicable.
At least 12 years of post-J.D. legal experience, including significant experience advising on pharmaceutical, biotechnology, biologics, or life sciences regulatory matters.
Deep knowledge of U.S. FDA requirements governing drug or biologic development, approval, labeling, pharmacovigilance, and post-marketing activities.
Significant experience advising on regulatory submissions, agency interactions, product development strategy, regulatory compliance, and lifecycle management.
Strong business acumen and ability to provide practical, strategic, risk-based legal advice in a complex, highly regulated environment.
Exceptional written and verbal communication skills, sound judgment, and ability to influence senior leaders and cross-functional stakeholders.
Excellent analytical, organizational, and problem-solving skills, with ability to manage multiple sophisticated matters and competing priorities.
Strategic thinking, business judgment, and regulatory risk-assessment skills.
Collaborative, pragmatic, solutions-oriented approach and ability to translate complex regulatory requirements into practical business guidance.
Executive presence and ability to build trusted relationships with senior leaders.
Demonstrated commitment to integrity, patient focus, and BioMarin’s values.

Nice To Haves

Prior experience working at or directly with the FDA is strongly preferred.
Significant in-house experience supporting a Global Regulatory Affairs organization within a biotechnology or pharmaceutical company.
Experience advising on global regulatory matters involving major international health authorities.
Experience supporting rare disease, specialty medicine, biologic, gene therapy, or other innovative therapeutic programs.
Experience advising across multiple products, therapeutic areas, and stages of development.
Ability to work onsite at BioMarin headquarters in San Rafael, California, at least three days per week is strongly preferred.

Responsibilities

Serve as the primary legal advisor to BioMarin’s Global Regulatory Affairs organization and provide practical, risk-based counsel on matters affecting investigational and approved products.
Advise Regulatory Affairs, product teams, and senior leadership on interactions with the FDA and other global health authorities.
Partner with Regulatory Affairs leaders to develop and execute global regulatory strategies supporting 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.
Counsel cross-functional teams on legal and regulatory considerations throughout product development, clinical development, marketing applications, approvals, and post-approval activities.
Review and advise on regulatory submissions, briefing materials, and correspondence with health authorities.
Provide legal guidance for 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 pathways relevant to innovative medicines.
Advise on lifecycle management initiatives, post-marketing commitments, evolving requirements, and agency expectations.
Partner with Regulatory Affairs leadership to identify and mitigate risks affecting development timelines, approvals, supply continuity, or marketed products.
Advise on the regulatory implications of business, development, and portfolio decisions across products and jurisdictions.
Provide strategic legal guidance on developing, negotiating, maintaining, and implementing product labeling, including global requirements, core labeling strategy, and consistency across jurisdictions.
Collaborate with Pharmacovigilance and Safety teams on adverse event reporting, signal management, risk management plans, risk evaluation and mitigation strategies, and other post-marketing safety obligations.
Advise on safety reporting, inspections, audits, investigations, communications with health authorities, post-marketing commitments, and related compliance activities.
Collaborate with Legal, Compliance, Quality, Clinical Development, Medical Affairs, Commercial, Government Affairs, and other stakeholders to provide coordinated legal support.
Translate complex legal and regulatory requirements into clear, practical guidance for senior leaders and cross-functional teams.
Monitor regulatory and enforcement developments and provide timely, actionable advice on their potential impact on pipeline and marketed products.
Develop and deliver training, policies, and practical resources to strengthen regulatory compliance and organizational capabilities.
Manage outside counsel and contribute to Legal Department initiatives, process improvements, knowledge sharing, and team development.
Support environmental protection, injury prevention, and continual improvement of EHS management systems; identify hazards, report incidents, and participate in EHS initiatives and training.