Vice President, Global Regulatory Therapeutic Lead

uniQure; Lexington (MA); On-site; USD 309,000 - 399,000; Full time

Job summary

uniQure is seeking a VP, Global Regulatory Therapeutic Lead to provide strategic and operational leadership for global regulatory activities across the company’s rare neurology portfolio. You will oversee integrated regulatory strategies from early development through post‑approval, partnering with cross‑functional teams to ensure compliant paths to approval in global markets.

You will lead Health Authority engagement with FDA/EMA/MHRA, drive regulatory excellence, and mentor senior regulatory

Qualifications

• Bachelor’s degree in Life Sciences or related field is required.
• 15+ years of progressive Regulatory Affairs with 5+ years in leadership/management.
• Experience with gene/cell therapy regulatory aspects is highly desirable.

Responsibilities

• Provide senior regulatory leadership and oversight for rare disease programs across full product lifecycle.
• Mentor and develop Regulatory Strategy Leads for assigned programs.
• Accountable for regulatory strategy input into governance and risk assessment.
• Develop global Health Authority engagement strategies (FDA, EMA, MHRA) and oversee major interactions.
• Oversee preparation and approval of high‑quality regulatory submissions (INDs/CTAs, BLAs/MAAs, etc.).
• Drive alignment of therapeutic and device development strategies and regulatory pathways.

Skills

Strategic regulatory leadership

Global regulatory strategy development

Leadership and mentoring

Health Authority engagement

Regulatory risk assessment

Excellent communication

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred (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, Global Regulatory Therapeutic Lead, 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, the VP will function as a key regulatory advisor and thought partner to senior leadership and cross‑functional governance bodies. The VP, Global Regulatory Therapeutic Lead 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 Global Regulatory Therapeutic Lead will 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 adapt 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.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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].