Senior Director, Corporate Counsel, Global Regulatory Affairs

BioMarin Pharmaceutical Inc.•San Rafael, CA

8d•Onsite

About The Position

BioMarin seeks an experienced, strategic, business-oriented attorney to serve as lead legal advisor to its Global Regulatory Affairs organization. The role provides legal counsel across the lifecycle of innovative therapies, from early development through global registration, commercialization, and post-approval activities. The attorney partners with Regulatory Affairs, Clinical Development, Medical Affairs, Pharmacovigilance, Quality, Commercial, and other stakeholders to support regulatory strategy and execution worldwide. The position advises on regulatory submissions, health-authority interactions, product approvals and labeling, pharmacovigilance obligations, post-marketing commitments, and evolving global regulatory requirements. It offers the opportunity to influence regulatory and development decisions across multiple products and therapeutic areas while advising senior business and regulatory leaders. Onsite work at BioMarin’s San Rafael, California headquarters at least three days per week is strongly preferred.

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, strong business judgment, and regulatory risk-assessment skills.
Collaborative, pragmatic, solutions-oriented approach.
Ability to translate complex regulatory requirements into practical business guidance.
Strong executive presence and ability to build trusted relationships with senior leaders.
Commitment to integrity, patient focus, and BioMarin’s values.

Nice To Haves

Prior experience working at or directly with the FDA.
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.

Responsibilities

Serve as the primary legal advisor to Global Regulatory Affairs and provide practical, risk-based counsel on regulatory 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 the 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 health-authority correspondence.
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 regulatory pathways.
Advise on lifecycle management initiatives, post-marketing commitments, and evolving regulatory 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 regulatory implications of business, development, and portfolio decisions across products and jurisdictions.
Provide legal guidance on development, negotiation, maintenance, and implementation of 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, required studies, and regulatory compliance for approved products.
Coordinate legal support with Legal, Compliance, Quality, Clinical Development, Medical Affairs, Commercial, Government Affairs, and other stakeholders.
Translate complex legal and regulatory requirements into clear, practical guidance for senior leaders and cross-functional teams.
Monitor significant regulatory and enforcement developments and advise 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 the organization’s environmental protection, injury prevention, and continual improvement of EHS management systems by identifying hazards, reporting incidents, and participating in EHS initiatives and training.