Global Regulatory Strategy Executive – Rare Disease

Regulatory Jobs; Lexington (MA); Remote; USD 309.000 - 399.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Global regulatory leadership

Strategic thinking

Regulatory strategy worldwide

Stakeholder influence

Regulatory risk assessment

Health Authority engagement

Leadership and mentoring

Communication skills

Ausbildung

Bachelor’s degree in Life Sciences

Advanced degree (MS/PhD/PharmD/MD)

Jobbeschreibung

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.