Executive Director, Regulatory CMC & Devices

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 Executive Director, Regulatory Affairs CMC & Device will provide strategic leadership for global regulatory CMC and device activities across the company’s rare disease portfolio. The Executive Director will provide integrated CMC and device regulatory strategies and its translation into operational goals across the product lifecycle, from early clinical development through post-approval lifecycle management. As a core member of the CMC Regulatory Affairs team, the Executive Director provides functional leadership within CMC Regulatory and to cross-functional teams.

This position requires deep regulatory expertise in the CMC aspects of gene-therapy drug development, strong people-leadership capabilities, and the ability to effectively collaborate in a highly matrixed environment, partnering closely with senior leaders in Technical Operations, Analytical-, Product-Development, and Quality.

Key result areas (major duties, accountabilities and responsibilities)

• Strategic & Operational Leadership: Set the vision and strategic direction for regulatory CMC activities supporting gene-therapy development, translating corporate goals into robust global regulatory strategies and operational goals, and oversee their execution for the assigned portfolio of products, from early development through post-marketing.
• Combination Product & Device Execution: Lead the formulation and implementation of regulatory strategies for combination products and device/biologics interfaces; collaborate closely with Therapeutic Regulatory Leads to align CMC, device, and clinical development strategies to achieve corporate objectives.
• Functional & Resource Management: Contribute to the development of the global CMC Regulatory team.
• Strategy Delivery: Provide CMC and Device regulatory strategy input to the product specific Global Regulatory Strategy and Plan (GRSP) including assessment of regulatory risk, probability of regulatory success, and mitigation strategies to support informed decision‑making by senior leadership.
• Health Authority Interactions: Provide strategic leadership for CMC Health Authority engagements (including FDA/CBER/CDRH, EMA, MHRA); serve as the senior functional lead for major regulatory interactions (e.g., pre-IND, End-of-Phase, scientific advice, pre-BLA/MAA, pre-Subs) in partnership with Therapeutic Leads.
• Submission Strategy & Oversight: Provide strategic oversight of the quality, technical review, and timely submission of high-quality CMC and device regulatory documentation, including INDs/CTAs, scientific advice packages, BLAs/MAAs, and responses to agency queries.
• Partner closely within the global regulatory affairs team and with relevant cross-functional teams to ensure alignment of regulatory CMC strategies.
  Provide strategic direction and seek alignment with relevant cross-functional stakeholders regarding the implementation of phase appropriate CMC and device regulatory requirements to the manufacture and control of uniQure products.
• Regulatory Intelligence & Application: Monitor evolving regulatory guidelines, precedents, and industry trends regarding cell/gene therapies and devices, rapidly translating this intelligence into strategic and operational adjustments to maintain a competitive advantage.
• Process Excellence & Compliance: Be accountable for compliance with global regulatory requirements, while continuously driving the optimization of internal CMC regulatory policies, workflows, systems, and standard operating procedures (SOPs), in line with evolving industry best practices.
• Governance: Represent Regulatory CMC and Device in cross functional committees and senior governance forums.

Qualifications & Skills

• Bachelor’s degree in a relevant scientific or engineering discipline; advanced scientific degree (MS, PharmD or PhD) strongly preferred.
• 15+ years of progressive Regulatory Affairs experience within the pharmaceutical and/or biotechnology industry (gene therapy and biologics).
• Leadership experience: Successful experience in leading a diverse community of professionals in a global and matrix environment is required, including workforce and budget planning. (Seasoned leader, decision maker and constructive challenger)
• Experience with the unique CMC and device regulatory aspects of gene and/or cell therapy products is highly desirable.
• Demonstrated success leading global CMC and device combination product regulatory strategies for multiple development programs across clinical stages (Phase 1–4), including experience with global registrations.
• Post marketing experience including management of CMC regulatory activities supporting marketed products, lifecycle management, variations and regulatory commitments.
• Proven experience interacting with global Health Authorities (e.g., FDA, EMA) at a strategic level.
• RAPS Regulatory Affairs Certification (RAC-Drugs and/or RAC-Devices), a plus
• Demonstrated experience leading the build and development of regulatory CMC teams in a matrixed, cross‑functional environment.
• Demonstrated deep knowledge of global regulatory requirements governing Advanced Therapy Medicinal Products.
• Demonstrated strong strategic thinking, risk assessment, 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.