VP, Regulatory Advertising & Promotion Strategy

uniQure; Lexington (MA); On-site; USD 309,000 - 399,000; Full time

Job summary

uniQure is seeking a Vice President, Advertising and Promotion Regulatory Affairs to lead US promotional compliance and strategy for prescription products including gene therapies. You will serve as the expert on FDA regulations and liaise with FDA’s APLB, ensuring submissions and labeling reflect current requirements.

The role requires 12+ years in regulatory affairs for promotion, with deep knowledge of US promotional regulations, labeling, and risk management.

Qualifications

• Degree in life science; advanced degree preferred.
• 12+ years’ experience in Regulatory Affairs promotion and advertising for prescription products.
• Deep expertise in FDA Ad/Promo landscape.
• Experience in rare diseases and gene therapy is essential.
• Proven independent regulatory reviewer for promotional materials.
• Experience with APLB submissions and 30-day submissions for Subpart H products.
• Knowledge of US regulations for drug promotion and labeling.
• Strong leadership and communication in matrix environments.

Responsibilities

• Lead regulatory review for promotional, medical education and corporate materials for US compliance.
• Apply regulatory and therapeutic knowledge to Brand Team objectives to resolve complex issues.
• Monitor major US regulatory promotional activity and industry meetings.
• Present learnings from FDA comments and enforcement actions to senior leadership.
• Serve as liaison with FDA’s APLB and manage 2253 submissions.
• Ensure Prescribing Information changes are reflected in promotions.
• Contribute metrics and process improvements to the promotional review workflow.
• Operate independently, escalating risks to senior leadership when needed.

Skills

FDA Ad/Promo

Regulatory affairs

Promotional review

Cross-functional leadership

Gene therapy

APLB submissions

US labeling

Education

PharmD / PhD / MS / JD

Tools

Veeva PromoMats

RIM

Job description

uniQure is seeking a Vice President, Advertising and Promotion Regulatory Affairs to lead US promotional compliance and strategy for prescription products including gene therapies. You will serve as the expert on FDA regulations and liaise with FDA’s APLB, ensuring submissions and labeling reflect current requirements.

The role requires 12+ years in regulatory affairs for promotion, with deep knowledge of US promotional regulations, labeling, and risk management.