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San Rafael, California, United States
Hybrid
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Director, Corporate Counsel, Global Regulatory Affairs based in the United States.
This senior legal leadership role offers the opportunity to shape global regulatory strategy for innovative medicines addressing serious and rare genetic diseases. As the primary legal advisor to the Global Regulatory Affairs organization, you will provide strategic counsel throughout the entire product lifecycle, from early clinical development to global approvals, commercialization, and post-marketing activities. You will work closely with regulatory, clinical, medical, quality, safety, commercial, and legal teams to navigate complex regulatory frameworks across multiple jurisdictions. By translating evolving legal requirements into practical, business-oriented guidance, you will help mitigate risks, support critical development decisions, and advance regulatory excellence. This position combines high-level strategic influence with hands-on legal expertise in a collaborative, science-driven environment. It is an opportunity to make a meaningful contribution to the development and availability of transformative therapies for patients with significant unmet medical needs.
Strategic Regulatory Counsel: Serve as the principal legal advisor to the Global Regulatory Affairs organization, providing practical, risk-based guidance on regulatory matters affecting investigational and approved products. Advise senior leaders on regulatory strategy, agency engagement, emerging legal developments, and potential risks or opportunities across the global portfolio.
Product Development and Regulatory Approvals: Support legal and regulatory activities throughout the product lifecycle, including early and clinical development, marketing applications, product approvals, and post-approval changes. Review regulatory submissions, briefing documents, and correspondence with health authorities, and provide legal guidance for agency meetings, inspections, inquiries, and investigations.
Global Regulatory Strategy and Lifecycle Management: Partner with regulatory leadership and product teams to develop and execute global strategies aligned with development priorities and business objectives. Advise on evolving regulatory requirements, expedited development and review pathways, orphan drug designations, pediatric development obligations, regulatory exclusivities, and post-marketing commitments. Identify and mitigate risks that could affect approval timelines, product availability, or ongoing commercialization.
Product Labeling: Provide strategic legal advice on the development, negotiation, maintenance, and implementation of labeling for investigational and approved medicines. Collaborate with regulatory and cross-functional teams to address labeling negotiations with health authorities, interpret global labeling requirements, and maintain appropriate consistency across jurisdictions.
Pharmacovigilance and Post-Marketing Compliance: Advise Pharmacovigilance and Safety teams on adverse event reporting, safety signal management, risk management plans, risk evaluation and mitigation strategies, and other post-marketing obligations. Support regulatory compliance activities, required studies, inspections, audits, investigations, and communications with health authorities.
Cross-Functional Leadership and Compliance: Work closely with Legal, Compliance, Quality, Clinical Development, Medical Affairs, Commercial, Government Affairs, and other stakeholders to deliver coordinated legal support. Translate complex regulatory requirements into clear, actionable recommendations, monitor relevant regulatory and enforcement developments, and develop training, policies, and resources that strengthen organizational compliance.
Legal Operations and Team Contribution: Manage external counsel and contribute to legal department initiatives, knowledge sharing, process improvements, and team development. Build trusted relationships with senior stakeholders and promote a collaborative, pragmatic, and solutions-oriented approach to regulatory legal matters.
Education and Professional Credentials: Juris Doctor (J.D.) degree from an accredited law school and active membership in at least one U.S. state bar. Eligibility for registered in-house counsel status in California, where applicable, is also required.
Relevant Legal Experience: At least 12 years of post-J.D. legal experience, including substantial experience advising on pharmaceutical, biotechnology, biologics, or broader life sciences regulatory matters.
Regulatory and FDA Expertise: Deep knowledge of U.S. Food and Drug Administration (FDA) requirements governing drug and biologic development, regulatory approval, product labeling, pharmacovigilance, and post-marketing activities. Demonstrated experience advising on regulatory submissions, interactions with health authorities, product development strategies, regulatory compliance, and lifecycle management.
Strategic and Business Acumen: Strong commercial awareness and the ability to deliver practical, risk-based legal advice in complex, highly regulated environments. Proven ability to assess regulatory risks, anticipate challenges, and align legal recommendations with scientific, operational, and business priorities.
Communication and Stakeholder Management: Exceptional written and verbal communication skills, sound professional judgment, and the ability to influence senior executives and multidisciplinary teams. Strong analytical, organizational, and problem-solving capabilities, with the ability to manage sophisticated matters and competing priorities effectively.
Preferred Regulatory Background: Previous employment at or direct experience working with the FDA is strongly preferred. Significant in-house experience supporting a Global Regulatory Affairs organization within a biotechnology or pharmaceutical company is highly desirable, as is experience advising on global regulatory matters involving major international health authorities.
Therapeutic and Product Experience: Experience supporting rare disease, specialty medicine, biologic, gene therapy, or other innovative therapeutic programs is advantageous. The ability to advise across multiple products, therapeutic areas, jurisdictions, and stages of development is particularly valuable.
Leadership Competencies: Demonstrated strategic thinking, regulatory risk assessment, executive presence, and relationship-building skills. A collaborative, pragmatic, and solutions-oriented mindset, combined with a strong commitment to integrity, patient focus, and ethical decision-making, is essential.
Location and Work Arrangement: The role is based in the United States, with a preference for candidates able to work onsite at the company's headquarters in San Rafael, California, at least three days per week. Remote candidates based in the Washington, D.C., area may also be considered.
Strategic Leadership Opportunity: Take on a high-impact legal leadership role influencing regulatory strategy, product development, approvals, and lifecycle management across an innovative therapeutic portfolio.
Meaningful Patient Impact: Contribute to the development and availability of treatments for people living with rare genetic diseases and other serious medical conditions.
Collaborative Environment: Work alongside multidisciplinary experts across Legal, Regulatory Affairs, Clinical Development, Medical Affairs, Quality, Pharmacovigilance, and Commercial functions.
Professional Growth: Gain broad exposure to global regulatory challenges, senior-level decision-making, innovative therapies, and complex legal matters across multiple jurisdictions.
Flexible Work Arrangements: Hybrid work in San Rafael, California, is preferred, with a remote arrangement potentially available for candidates based in the Washington, D.C., area.
Compensation and Benefits: Salary range, bonus eligibility, healthcare coverage, retirement plans, paid time off, and other employment benefits were not specified in the source description and should be confirmed with the hiring company.