Role Overview for VP Regulatory Strategy, Biopharma – Boston, MA
JRG Partners is proud to represent a pioneering, clinical-stage biopharmaceutical company at the forefront of developing transformative therapies for diseases with high unmet medical needs. Located in the vibrant biotech hub of Boston, MA, our client is driven by a culture of scientific excellence, innovation, and a deep commitment to patient outcomes. We are seeking a visionary and highly experienced Vice President of Regulatory Strategy to join their executive leadership team and steer the global regulatory direction of their promising pipeline.
This is a pivotal leadership role that offers the unique opportunity to shape the regulatory future of a dynamic organization. The VP of Regulatory Strategy will be the principal architect of the company’s global regulatory roadmap, providing strategic insight and hands-on leadership across the entire product lifecycle, from preclinical development through to post-marketing commitments. Reporting directly to the Chief Medical Officer, you will be responsible for building and mentoring a world-class regulatory affairs team, fostering strong relationships with global health authorities, and ensuring that all regulatory activities are executed flawlessly to accelerate the delivery of novel medicines to patients worldwide. The ideal candidate is a strategic thinker with a proven track record of successful drug approvals, an expert in navigating the complexities of the global regulatory landscape, and a passionate leader capable of inspiring a team to achieve ambitious goals. This position requires a deep understanding of the science behind drug development and the commercial acumen to align regulatory strategy with business objectives.
Key Responsibilities of VP Regulatory Strategy, Biopharma – Boston, MA
Strategic Regulatory Leadership
Develop, articulate, and execute innovative and forward-thinking global regulatory strategies for the company’s entire portfolio. Provide expert regulatory counsel to the executive team, project teams, and functional areas to ensure that all development programs are optimized for successful and timely approvals in key markets.
Health Authority Engagement
Act as the primary, high-level point of contact with global health authorities, including the FDA, EMA, and other national agencies. Lead the strategy, preparation, and execution of critical agency meetings (e.g., Pre-IND, End-of-Phase 2, Pre-BLA/NDA meetings), ensuring clear communication and fostering positive, collaborative relationships.
Team Development and Management
Recruit, lead, and mentor a high-performing regulatory affairs team, encompassing strategy, operations, and advertising/promotion. Cultivate a culture of accountability, scientific rigor, and continuous improvement. Provide guidance and professional development opportunities to team members to build a robust internal talent pipeline.
High-Quality Submissions
Provide ultimate oversight for the planning, preparation, and submission of all regulatory dossiers, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), Biologics License Applications (BLAs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and all subsequent variations and supplements. Ensure all submissions are of the highest quality and adhere to regulatory requirements.
Cross-Functional Collaboration
Serve as a key strategic partner to cross-functional teams, including Clinical Development, Nonclinical, CMC, Quality, and Commercial. Integrate regulatory strategy seamlessly into overall drug development plans, providing proactive guidance on regulatory risks and opportunities.
Regulatory Intelligence and Policy
Proactively monitor, interpret, and analyze the evolving global regulatory landscape, including new legislation, guidelines, and industry trends. Disseminate this intelligence throughout the organization and leverage it to adapt and refine regulatory strategies, ensuring a competitive advantage.
Compliance and GxP Oversight
Guarantee that all regulatory activities are conducted in strict compliance with global regulations and company SOPs. Provide regulatory input and oversight for GxP (GCP, GLP, GMP) activities, including clinical trial conduct, manufacturing processes, and labeling.
Business Development Support
Offer senior-level regulatory expertise to support business development activities, such as due diligence for potential in-licensing, out-licensing, or M&A opportunities. Assess the regulatory viability and risks associated with external assets.
Budget and Resource Management
Develop and manage the departmental budget, ensuring efficient allocation of resources to meet strategic objectives. Oversee relationships with regulatory consultants and vendors to supplement internal capabilities as needed.
Requirements for the VP Regulatory Strategy, Biopharma – Boston, MA
Educational Background
An advanced degree (PhD, PharmD, MD, or MS) in a relevant life sciences discipline is required.
Professional Experience
A minimum of 15 years of progressive and relevant experience in regulatory affairs within the biotechnology or pharmaceutical industry. At least 7 years of experience in a senior leadership role, with demonstrated success in managing and developing teams.
Regulatory Expertise
A proven track record of leading successful major regulatory submissions that have resulted in approvals in the US and/or Europe. Extensive experience across all phases of drug development, from preclinical to post-approval life cycle management, is essential.
Therapeutic and Modality Experience
Direct experience with biologics is required. Experience in specific therapeutic areas such as oncology, immunology, or rare diseases is highly desirable. Familiarity with cell and gene therapies or other advanced modalities would be a significant asset.
Health Authority Interactions
Extensive, first-hand experience leading formal meetings and negotiations with the U.S. Food and Drug Administration (FDA), particularly CBER and/or CDER, as well as the European Medicines Agency (EMA). Must have the executive presence and communication skills to represent the company effectively.
Strategic Acumen
Must be a strategic thinker with the ability to integrate regulatory science with business objectives. Capable of identifying creative and compliant solutions to complex regulatory challenges.
Leadership Skills
Exceptional leadership, influencing, and interpersonal skills. A demonstrated ability to lead and motivate a team, build consensus across functions, and communicate complex information clearly to diverse audiences, including executive leadership and boards of directors.
Location
The position is based in Boston, MA, and requires the ability to work in a hybrid model, combining in-office collaboration with remote flexibility.
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 professional and personal well-being. This includes:
Executive Compensation
A competitive base salary, a significant annual performance-based bonus, and a substantial long-term equity package (stock options and/or RSUs).
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance for you and your dependents, a flexible spending account (FSA), and a health savings account (HSA). Access to wellness programs, mental health support, and a fitness stipend.
Retirement Savings
A robust 401(k) retirement plan with a generous company matching contribution.
Work-Life Balance
A flexible paid time off (PTO) policy, numerous paid company holidays, and comprehensive parental leave policies.
Professional Growth
A dedicated budget for professional development, including attendance at major industry conferences, workshops, and continuing education courses.
Relocation Support
A comprehensive relocation assistance package is available for exceptional candidates moving to the Boston area.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. To be considered for this career-defining opportunity, please submit your resume and a cover letter detailing your qualifications and interest in the role. We encourage you to learn more about our expertise in this field by visiting Top Regulatory Affairs Executive Recruiters practice area. Our team will review all applications and contact qualified candidates directly for a confidential discussion.
Our client is an equal opportunity employer and values diversity at their company. They do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
