Vice President, Global Regulatory Therapeutic Lead

Role: Vice President, Global Regulatory Therapeutic Lead, providing strategic and operational leadership for regulatory activities across uniQure's rare neurology portfolio. Objectives include developing and executing integrated global regulatory strategies from early clinical development through post-approval, ensuring efficient pathways to market. Responsibilities encompass overseeing global Health Authority engagements (FDA, EMA, MHRA), managing regulatory submissions (INDs, BLAs/MAAs, orphan drug applications), guiding regulatory risk assessment, and supporting regulatory pathways like Orphan Drug and Breakthrough Therapy designations. The role involves mentoring regulatory teams, aligning therapeutic and device development strategies, and ensuring compliance with international regulatory standards. Qualifications: Bachelor's in Life Sciences or related field, with 15+ years of progressive experience in biotech/pharma regulatory affairs, including at least 5 years in leadership. Deep expertise in gene/cell therapy and neurology/regulatory aspects of rare diseases is required. Proven success in managing global regulatory strategies and authority interactions, with strong strategic, risk assessment, and cross-functional collaboration skills. Experience in biotech/biopharma (gene therapy, biologics), regulatory submissions, and global health authority negotiations is essential. Work setup: Remote with a global scope, involving strategic leadership and stakeholder engagement at the enterprise level.