Global Regulatory Lead for Gene Therapy (Remote)

Scorpion Therapeutics; United States; Remote; USD 350,000 - 550,000; Full time

Job summary

uniQure is seeking a Vice President, Global Regulatory Therapeutic Lead to provide strategic and operational leadership for regulatory activities across its rare neurology portfolio. You will develop and execute integrated global regulatory strategies from early clinical development through post-approval to enable efficient market access.

The role involves overseeing Health Authority engagements, managing submissions, and guiding risk assessment while mentoring regulatory teams and aligning

Qualifications

• Bachelor's in Life Sciences or related field required.
• 15+ years of progressive biotech/pharma regulatory affairs experience.
• At least 5 years in leadership or management roles.

Responsibilities

• Overseeing global Health Authority engagements (FDA, EMA, MHRA).
• Managing regulatory submissions (INDs, BLAs/MAAs, orphan drug applications).
• Guiding regulatory risk assessment and strategy development.
• Supporting pathways like Orphan Drug and Breakthrough Therapy designations.
• Mentoring regulatory teams and aligning development strategies.

Skills

Regulatory leadership

Global regulatory strategy

Strategic planning

Cross-functional collaboration

Risk assessment

Stakeholder management

Education

Bachelor's degree in Life Sciences or related field

Job description

uniQure is seeking a Vice President, Global Regulatory Therapeutic Lead to provide strategic and operational leadership for regulatory activities across its rare neurology portfolio. You will develop and execute integrated global regulatory strategies from early clinical development through post-approval to enable efficient market access.

The role involves overseeing Health Authority engagements, managing submissions, and guiding risk assessment while mentoring regulatory teams and aligning