Role Overview for EVP, Global Regulatory Affairs with a Biopharma Start-up – Cambridge, MA
JRG Partners is proud to partner with a pioneering, well-funded biopharmaceutical start-up in Cambridge, MA, to identify a visionary Executive Vice President (EVP) of Global Regulatory Affairs. This is a rare and transformative opportunity to join an executive leadership team poised to redefine treatment paradigms in their therapeutic area.
As the EVP, you will be the chief architect of the company’s global regulatory strategy, providing the critical leadership needed to navigate complex regulatory landscapes and bring novel, life-changing therapies from concept to patients worldwide. This role is not merely about compliance; it is about strategic foresight, innovative problem-solving, and building a world-class regulatory function from the ground up.
Sitting at the heart of the Cambridge biotech ecosystem, you will leverage your deep expertise to influence every stage of product development. You will be the primary voice of the company to global health authorities, building relationships based on trust, transparency, and scientific rigor.
This executive role demands a leader who is both a strategic thinker and a hands-on operator, capable of steering the company through critical regulatory milestones while mentoring a growing team. If you are a seasoned regulatory leader passionate about building something meaningful and making a tangible impact on human health, this position offers an unparalleled platform for professional achievement and personal fulfillment.
Key Responsibilities of EVP, Global Regulatory Affairs with a Biopharma Start-up – Cambridge, MA
Strategic Leadership and Vision
Serve as a key member of the executive leadership team, contributing to the overall corporate strategy and direction. You will develop, articulate, and execute a comprehensive, forward-thinking global regulatory strategy for the company’s entire portfolio, ensuring alignment with business objectives, clinical development plans, and commercial goals. This includes defining regulatory pathways, assessing risks, and identifying opportunities for expedited approvals.
Health Authority Engagement
Act as the primary, high-level liaison between the company and global regulatory agencies, including the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), PMDA (Japan), and other key international bodies. You will lead the strategy for and participate in critical meetings and negotiations with these authorities, fostering positive and productive relationships.
Regulatory Submissions Oversight
Provide expert leadership for the planning, preparation, and submission of all regulatory filings. This encompasses the full lifecycle of product development, from pre-IND/CTA packages, INDs (Investigational New Drug applications), and CTAs (Clinical Trial Applications) to marketing applications such as NDAs (New Drug Applications), BLAs (Biologics License Applications), and MAAs (Marketing Authorisation Applications), as well as post-approval supplements and variations.
Cross-Functional Collaboration
Provide robust regulatory guidance and strategic input to all functional areas, including Clinical Development, Nonclinical, CMC (Chemistry, Manufacturing, and Controls), Quality Assurance, and Commercial. You will ensure that regulatory requirements and strategies are integrated into all development plans from the earliest stages, preventing delays and maximizing the probability of success.
Team Building and Mentorship
Recruit, develop, and lead a high-performing global regulatory affairs department. You will be responsible for building the necessary infrastructure, processes, and talent to support the company’s growing pipeline. This includes fostering a culture of excellence, collaboration, and continuous learning within your team.
Regulatory Intelligence and Policy
Proactively monitor, interpret, and analyze the evolving global regulatory landscape, including new regulations, guidance documents, and industry trends. You will advise the executive team and the broader organization on the potential impact of these changes and develop strategies to adapt and thrive in a dynamic environment.
Compliance and Governance
Ensure that all company activities, from research and development to manufacturing and commercialization, are conducted in full compliance with applicable global regulatory requirements. You will oversee regulatory operations, including publishing and submissions, and establish robust internal governance frameworks.
Due Diligence and Business Development
Provide critical regulatory expertise for due diligence activities related to potential in-licensing, out-licensing, partnerships, and acquisitions. You will assess the regulatory risks and opportunities of external assets to inform strategic business decisions.
Requirements for the EVP, Global Regulatory Affairs with a Biopharma Start-up – Cambridge, MA
Educational Foundation
An advanced degree (MD, PhD, PharmD) in a relevant life sciences discipline is strongly preferred. A Bachelor’s or Master’s degree with extensive, directly relevant experience will be considered.
Executive Experience
A minimum of 15-20 years of progressive experience in the biopharmaceutical industry, with at least 10 years in a leadership role within Global Regulatory Affairs.
Proven Track Record of Success
Demonstrated success in leading the development and execution of global regulatory strategies for novel therapeutics, resulting in successful IND/CTA filings and major marketing application approvals (NDA/BLA/MAA) in the US and EU.
Global Expertise
Deep and comprehensive understanding of global regulatory requirements, including FDA, EMA, and ICH guidelines. Experience with regulatory processes in other key markets (e.g., Japan, China) is highly desirable.
Therapeutic Versatility
Broad experience across different therapeutic areas and modalities (e.g., small molecules, biologics, cell and gene therapy, rare diseases, oncology) is a significant asset.
Leadership and Influence
Exceptional leadership, communication, and interpersonal skills. Proven ability to build and lead high-performing teams, influence cross-functional stakeholders, and effectively represent the company before regulatory authorities and external partners.
Strategic and Analytical Acumen
Strong strategic thinking capabilities combined with a detail-oriented, analytical approach. The ability to anticipate regulatory hurdles, develop innovative solutions, and make sound decisions in a fast-paced, data-driven environment.
Entrepreneurial Spirit
Experience in a start-up or small, rapidly growing biotech environment is highly preferred. The ideal candidate will be adaptable, resourceful, and comfortable with ambiguity, possessing a ‘roll-up-your-sleeves’ mentality.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
Executive Compensation
A competitive base salary and an attractive annual performance-based bonus plan.
Meaningful Equity
A substantial equity stake (stock options) in the company, providing the opportunity to share directly in the success you help create.
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance plans for you and your dependents.
Retirement Planning
A 401(k) retirement savings plan with a generous company match.
Work-Life Balance
A flexible and generous paid time off (PTO) policy, including vacation, sick leave, and company holidays.
Professional Growth
A commitment to your professional development with support for attending conferences, workshops, and continuing education.
Relocation Support
A comprehensive relocation package is available for the right candidate.
Impactful Work
The invaluable opportunity to be a foundational leader in a company dedicated to developing groundbreaking medicines for patients with unmet medical needs.
How to Apply
JRG Partners is the exclusive recruitment firm for this executive search. To be considered for this pivotal role, please submit your resume and a cover letter detailing your qualifications and interest. We are seeking a leader who is not just qualified, but who is also aligned with the mission and culture of our client. All inquiries and applications will be handled with the strictest confidence.
For more information about our expertise in this sector, please visit our Life Sciences & Biotechnology Executive Search practice area. We look forward to connecting with you.
