Role Overview for VP, Global Regulatory Labeling with a Biologics Firm – San Francisco, CA
JRG Partners is proud to partner exclusively with a pioneering, research-driven biologics organization based in the vibrant life sciences hub of San Francisco, CA. We are seeking a visionary and strategic leader to assume the critical role of Vice President, Global Regulatory Labeling. This is a unique opportunity to shape the global labeling strategy for a portfolio of innovative biologic therapies that address significant unmet medical needs. The successful candidate will be a key member of the Global Regulatory Affairs leadership team, responsible for ensuring that all product labeling is accurate, compliant, and effectively communicates the product’s benefits and risks to patients and healthcare providers worldwide.
As the VP, Global Regulatory Labeling, you will provide executive oversight for the entire lifecycle of product labeling, from early development through post-marketing. You will lead a dedicated team of professionals responsible for the creation, maintenance, and management of Core Data Sheets (CDS), United States Prescribing Information (USPI), and European Union Summary of Product Characteristics (SmPC), as well as all associated regional and local labels. Your strategic guidance will be paramount in navigating the complex and evolving global regulatory landscape, ensuring timely approvals and maintaining compliance across all markets. This role demands a deep understanding of regulatory science, a passion for patient safety, and the executive presence to influence cross-functional stakeholders and senior leadership. You will be the central authority on all labeling matters, driving excellence and innovation in labeling processes and content to support the company’s global commercial and clinical objectives.
Key Responsibilities of VP, Global Regulatory Labeling with a Biologics Firm – San Francisco, CA
Strategic Leadership
Develop, articulate, and execute a forward-thinking global labeling strategy that aligns with the company’s long-term corporate objectives and evolving regulatory requirements. Provide strategic counsel to senior management on labeling-related risks, opportunities, and trends.
Global Labeling Oversight
Lead the end-to-end global labeling process, including the development, revision, and implementation of the Company Core Data Sheet (CCDS), USPI, and EU SmPC for all development and commercial-stage biologic products.
Team Development and Management
Build, lead, mentor, and develop a high-performing global regulatory labeling team. Foster a culture of collaboration, accountability, scientific rigor, and continuous improvement. Manage resource allocation and departmental budgets effectively.
Cross-Functional Collaboration
Chair or play a leading role in cross-functional Labeling Committees. Collaborate seamlessly with key stakeholders from Clinical Development, Pharmacovigilance, Medical Affairs, Legal, Quality Assurance, and Commercial teams to ensure labeling content is medically and scientifically accurate, consistent, and supported by data.
Regulatory Compliance and Intelligence
Serve as the internal subject matter expert on global labeling regulations and guidelines. Monitor the global regulatory environment for changes impacting labeling, and proactively develop strategies to address them. Ensure all labeling activities are conducted in strict compliance with FDA, EMA, and other global health authority regulations.
Health Authority Interactions
Lead the strategy for and participate in negotiations with global health authorities regarding labeling content. Ensure that all labeling-related submissions are of the highest quality and are submitted on time.
Process Optimization
Drive the continuous improvement of global labeling processes, systems, and SOPs to enhance efficiency, quality, and compliance. Champion the adoption of new technologies and best practices in labeling management.
Labeling Content Development
Oversee the authoring and review of labeling text, ensuring it is clear, concise, and accurately reflects the product’s data. Ensure consistency of labeling across product families and global markets where appropriate.
Risk Management
Partner with Pharmacovigilance and Clinical Safety to ensure that emerging safety information is appropriately evaluated and reflected in product labeling in a timely manner, effectively managing the benefit-risk profile of the company’s products.
Lifecycle Management
Provide strategic labeling input for products throughout their lifecycle, from target product profile development for early-stage candidates to post-approval updates and safety-related changes for marketed products.
Requirements for the VP, Global Regulatory Labeling with a Biologics Firm – San Francisco, CA
Educational Background
An advanced degree in a scientific or medical discipline (e.g., PharmD, PhD, MD) is strongly preferred. A Bachelor’s degree in a relevant field with extensive, directly applicable experience will be considered.
Professional Experience
A minimum of 15 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 10 years in a dedicated Regulatory Affairs labeling function. Significant experience with biologics is required.
Leadership Experience
A proven track record of at least 7 years in a leadership role, successfully managing and mentoring teams of regulatory professionals. Experience leading a global team is highly desirable.
Regulatory Expertise
Deep expertise in global labeling regulations, including a comprehensive understanding of relevant FDA regulations, EMA guidelines, and ICH standards. Direct experience leading labeling negotiations with major health authorities is essential.
Strategic Acumen
Demonstrated ability to think strategically, anticipate future trends, and translate regulatory requirements into actionable, business-oriented strategies.
Communication Skills
Exceptional written and verbal communication skills. Must be able to articulate complex regulatory and scientific issues clearly and persuasively to a variety of audiences, from technical experts to senior executives.
Interpersonal Skills
Strong influencing and negotiation skills with a demonstrated ability to build consensus and drive alignment across diverse, cross-functional teams in a matrixed environment.
Problem-Solving Abilities
Excellent analytical and problem-solving skills, with the ability to make sound, risk-based decisions in a fast-paced environment.
Location
Ability to work on-site at the company’s headquarters in San Francisco, CA, with a hybrid work model available.
Benefits & Perks Offered
Our client is committed to investing in their employees and offers a highly competitive and comprehensive benefits package, designed to support your health, well-being, and financial security. This includes:
Competitive Compensation
A highly competitive base salary, annual performance-based bonus, and a significant long-term equity incentive package (stock options/RSUs).
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance for you and your dependents. A robust wellness program, including gym memberships, mental health resources, and employee assistance programs.
Retirement Savings
A 401(k) plan with a generous company match to help you save for your future.
Paid Time Off
A generous paid time off (PTO) policy, including vacation, sick leave, and company-paid holidays, to promote work-life balance.
Professional Development
A strong commitment to your career growth, with support for attending conferences, continuing education, and internal leadership development programs.
Family Support
Comprehensive parental leave policies and family-building benefits.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. If you are a strategic regulatory labeling leader with a passion for science and a desire to make a tangible impact on patient lives, we encourage you to apply. To be considered for this pivotal role, please submit your resume and a cover letter detailing your qualifications.
JRG Partners is a leader in executive search for the life sciences industry. Explore this and other opportunities within our Life Sciences practice to advance your career with today’s most innovative companies.
