| Location | San Rafael, CA |
| Salary | $232,000–$319,000 Per Year |
b' Senior Director, Corporate Counsel, Global Regulatory Affairs | BioMarin
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San Rafael
BioMarin Pharmaceutical
Senior Director, Corporate Counsel, Global Regulatory Affairs
Location: San Rafael, United States
Workstyle: Hybrid
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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 peopleâ€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 - HYBRID IN SAN RAFAEL CA OR REMOTE IN WASHINGTON DC
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 activities involving approved products.
Cross-Functional Leadership
Collaborate closely 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 significant regulatory and enforcement developments and provide timely, actionable advice regarding their potential impact on BioMarin's 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.
Qualifications and Professional Experience
Required
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.
Minimum of 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 demonstrated ability to provide practical, strategic, and risk-based legal advice in a complex and highly regulated environment.
Exceptional written and verbal communication skills, sound judgment, and the ability to influence senior leaders and cross-functional stakeholders.
Excellent analytical, organizational, and problem-solving skills, with the ability to manage multiple sophisticated matters and competing priorities.
Preferred
Prior experience working at or directly with the FDA 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.
Leadership Competencies
Strategic thinker with strong business judgment and regulatory risk-assessment skills.
Collaborative, pragmatic, and 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.
Demonstrated commitment to integrity, patient focus, and BioMarin's values.
Location
Ability to work onsite at BioMarin headquarters in San Rafael, California at least three days per week strongly preferred.
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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.
Equal Opportunity Employer/Veterans/Disabled
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.
Ireland Safety Responsibility
Support the organisationâ€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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
The salary range for this position is: $232,000 to $319,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
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Recruitment Fraud Alert Notice
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.
In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.
If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.
For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you
Equal Opportunity Employer/Veterans/Disabled
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.
If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email Applicant_accommodations@bmrn.com with your request.
This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.
BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team â€" please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at talentacquisition@bmrn.com.
Applicants, please do not use this email address to submit resumes â€" if you do so, you will be redirected to apply through the website.
Click here to review "EEO Is The Law" poster. Click here to review the Pay Transparency Nondiscrimination Statement. Click here to review the Notification of Employee Rights under Federal Labor Laws.
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