Global Regulatory Lead: Gene Therapy & Rare Diseases

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

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