Vice President, Regulatory Strategy

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.

• 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…