Vice President, Regulatory Strategy

Regulatory Jobs; Lexington (MA); Remote; USD 309,000 - 399,000; Full time

Job summary

uniQure seeks a VP, Regulatory Strategy to lead global regulatory activities for our rare neurology portfolio from early development through post‑approval. You’ll drive strategies, mentor teams, and ensure bold, compliant pathways to approval across markets.

Lead Health Authority engagement (FDA/EMA/MHRA), align development with commercial goals, and influence decisions at the enterprise level in a fast‑paced biotech setting.

Qualifications

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• 15+ years in Regulatory Affairs with 5+ years in leadership.
• Gene/cell therapy regulatory experience desirable.
• Neurology/CNS regulatory exposure required.
• Proven global regulatory strategy experience with rare diseases.

Responsibilities

• Provide senior regulatory leadership for rare disease programs across lifecycle.
• Mentor Regulatory Strategy Leads and oversee governance inputs.
• Engage Health Authorities (FDA, EMA, MHRA) at strategic level.
• Prepare and negotiate high-quality regulatory submissions and interactions.
• Align therapeutic and device development strategies with portfolio goals.

Skills

Global regulatory leadership

Strategic thinking

Regulatory strategy worldwide

Stakeholder influence

Regulatory risk assessment

Health Authority engagement

Leadership and mentoring

Communication skills

Education

Bachelor’s degree in Life Sciences

Advanced degree (MS/PhD/PharmD/MD)

Job description

Place in the Organization

At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life‑changing treatments.

The Vice President, Regulatory Strategy, reporting to the Senior Vice President, Global Regulatory Affairs, will provide strategic and operational leadership for global regulatory activities across the company’s rare neurology portfolio and will be accountable for the development and execution of integrated global regulatory strategies across the product lifecycle, from early clinical development through registration, commercialization, and post‑approval lifecycle management.

Serving as a senior member of the Regulatory Affairs Leadership Team, will function as a key regulatory advisor and thought partner to senior leadership and cross‑functional governance bodies. The VP, Regulatory Strategy will ensure that regulatory strategies are aligned with corporate objectives, development priorities, and commercial goals, while enabling efficient and compliant pathways to approval in global markets.

This position requires deep regulatory expertise in rare disease drug development, strong leadership and decision‑making capabilities, and the ability to influence at the enterprise level. The VP, Regulatory Strategy fwill lead global Health Authority engagement strategies, drive regulatory excellence across the organization, and build and mentor high‑performing regulatory staff in a highly dynamic rare disease biotech environment.

Key result areas (major duties, accountabilities and responsibilities)

• Provide senior‑level regulatory leadership and oversight for assigned rare disease programs and/or portfolio segments, ensuring the development and execution of robust global regulatory strategies across the full product lifecycle, from early clinical development through registration, commercialization, and post‑approval activities.
• Mentor and develop Regulatory Strategy Leads for assigned programs/portfolio.
• Accountable for regulatory strategy input into corporate, portfolio, and development governance, including assessment of regulatory risk, probability of success, and mitigation strategies to support informed decision‑making by senior leadership.
• Ensure development of robust global Health Authority engagement strategies, including FDA (CBER), EMA, MHRA and other international regulatory agencies, and provide senior level oversight for major regulatory interactions (e.g., pre‑IND, End‑of‑Phase, scientific advice, pre‑BLA/MAA).
• Ensure the preparation, review, and approval of high‑quality regulatory submissions and related documentation, including but not limited to INDs/CTAs, scientific advice packages, orphan drug applications, PIPs/PSPs, BLAs/MAAs, labeling strategy and negotiations, responses to health authority questions, and post‑approval commitments.
• Ensure alignment of therapeutic and device development strategies.
• Drive the evaluation and application of special regulatory pathways and expedited programs (e.g., orphan drug designation, Breakthrough Therapy Designation, Fast Track designation, Regenerative Medicine Advanced Therapy designation, Accelerated Approval, PRIME, pediatric plans, Innovative Licensing and Access Pathway), ensuring alignment with portfolio objectives.
• Maintain a high level of regulatory intelligence and competitive awareness, monitor evolving regulatory requirements, precedents, and external trends, and proactively adapting regulatory strategies to maintain competitive advantage.
• Partner closely with Clinical Development, Clinical Operations, CMC/Technical Operations, Nonclinical, Biometrics, Medical Affairs, Commercial, and Project Management to ensure regulatory considerations are fully integrated into development and commercialization plans.
• Represent Regulatory Affairs as a senior leader within cross‑functional teams, asset strategy teams, and internal governance forums.
• Ensure compliance with global regulatory requirements and internal policies, and support continuous improvement of regulatory processes, systems, and capabilities to support organizational growth

Qualifications & Skills

• Bachelor’s degree in Life Sciences or a related discipline required; advanced scientific degree (MS, PhD, PharmD, MD, or equivalent) strongly preferred.
• 15+ years of progressive Regulatory Affairs experience within the pharmaceutical and/or biotechnology industry (gene therapy and biologics) with 5+ years of leadership and management experience.
• Experience with the unique regulatory aspects of gene and/or cell therapy products is highly desirable
• Experience in neurology and/or CNS is required.
• Demonstrated success leading global regulatory strategies and global expansion in rare disease.
• Proven experience interacting with global Health Authorities (e.g., FDA, EMA) at a strategic level.
• Experience negotiating patient reported outcomes (PROs) and other clinical outcomes assessments (COAs) with FDA and/or EMA.
• Demonstrated experience managing and developing senior regulatory leaders and teams as a player/coach in a matrixed, cross‑functional environment.
• Demonstrated deep knowledge of global regulatory requirements governing rare diseases.
• Demonstrated strong strategic thinking, risk assessment, problem solving and decision‑making capabilities.
• Ability to influence and collaborate effectively with senior leadership and cross‑functional stakeholders.
• Excellent written and verbal communication skills, including the ability to communicate complex regulatory issues to senior leadership.
• Demonstrated ability to deal with rapid change.

#LI-Remote

US Salary Range

$309,000—$399,000 USD

uniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws. If you need assistance or a reasonable accommodation during the application process, please contact [e-mail].