Vice President, Advertising and Promotion, Regulatory Affairs

Regulatory Toolkit; Lexington (MA); Hybride; USD 309 000 - 399 000; Plein temps

Résumé du poste

uniQure seeks a visionary Vice President, Advertising and Promotion Regulatory Affairs to lead US regulatory strategy for promotional materials and labeling in support of gene therapies.

The role requires deep FDA Ad/Promo expertise, 12+ years in regulatory affairs for prescription products, and strong leadership in matrixed settings.

Qualifications

• Degree in life science or equivalent; advanced degree preferred.
• Minimum of 12+ years’ experience in Regulatory Affairs promotion and advertising.
• Deep expertise in FDA Ad/Promo landscape.
• Experience leading APLB submissions and 30-day submissions for Subpart H products.
• Strong ability to communicate regulatory risk to stakeholders.

Responsabilités

• Leads regulatory review and approval for promotional, medical education and corporate materials for regulatory compliance.
• Applies regulatory knowledge to brand objectives and manages risks for US promotions.
• Monitors US regulatory promotional environment and industry guidance.
• Presents learnings to senior management and cross-functional teams.
• Liaises with FDA’s APLB and oversees submissions.

Connaissances

FDA Ad/Promo knowledge

Regulatory strategy

Negotiation with FDA

Leadership in matrixed environments

Gene therapy experience

Rare disease experience

Formation

Life science degree

Advanced degree preferred

Outils

Veeva PromoMats

RIM

Description du poste

At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.

The Vice President, Advertising and Promotion Regulatory Affairs will report to the Senior Vice President Global Regulatory Affairs. This position will be responsible for providing commercial regulatory and labeling strategy to enable the US business to meet its commercial needs in a compliant matter. The role will be an internal expert on the US FDA regulations, guidelines and trends governing the promotion of prescription products including gene therapies.

Key result areas (major duties, accountabilities and responsibilities)

• Leads regulatory review and approval for promotional, medical education and corporate materials to assess for regulatory compliance with the applicable regulations, guidance documents, and internal policies and best practices.
• Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to complex US promotional issues. Ensures global regulatory compliance while effectively managing business risks.
• Maintains awareness of competitive activities by monitoring major US medical congresses in assigned therapeutic area.
• Monitors US regulatory promotional environment by reviewing and interpreting regulatory promotional guidance documents, untitled and warning letters, and by attendance of major FDLI, DIA and other industry/FDA meetings to inform internal standards.
• Present to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
• Serve as the company's primary liaison with FDA’s APLB, including advisory comments, voluntary submissions and responses to inquiries for respective product(s) and ensures materials are submitted to FDA via 2253.
• Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
• Support input to metrics to measure and track the effectiveness and efficiency of the promotional review process and provide recommendations for process improvements to address potential issues.
• Operates independently, with recognition of when to consult senior leadership to identify and elevate risks.

Qualifications & Skills

• Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, JD) preferred.
• Minimum of 12+ years’ experience in Regulatory Affairs promotion and advertising working with prescription drug or biologic products.
• Deep expertise in FDA Ad/Promo landscape.
• Solution oriented and demonstrated skilled negotiator with internal stakeholders and FDA.
• Experience in a rare disease is essential and gene therapy is strongly preferred.
• Proven experience serving as the independent regulatory reviewer for promotional materials within a biotechnology or pharmaceutical company.
• Experience in leading activities for APLB submissions, including time of first use sub-missions, requests for advisory comments, and 30-day submissions for Subpart H products.
• Demonstrated knowledge and understanding of US regulations for drug promotion/advertising and US labeling.
• Demonstrated skill in evaluating potential regulatory risk within promotional materials and effectively communicating those risks in a clear, actionable manner to MLR stakeholders and cross-functional partners.
• Demonstrated leadership skills in highly matrixed environments.
• Ability to manage and bring working teams together for common objectives.
• Understanding of business goals of the business franchise, marketing concepts and tools.
• Proven ability to analyze and interpret efficacy and safety data.
• Excellent oral and written skills and project timeline management skills.
• Prior experience with launch readiness planning and execution.
• Prior experience with Veeva PromoMats and RIM.
• Flexible, entrepreneurial by nature, a collaborative team member.
• Proven track record of overseeing regulatory requirements outside US FDA (e.g. EMA, MHRA, Health Canada, PMDA).

#LI-Hybrid

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

US Salary Range

$309,000—$399,000 USD

uniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws. If you need assistance or a reasonable accommodation during the application process, please contact [e-mail].

uniQure processes personal data submitted through this application for recruitment and hiring purposes only. Depending on your location, you may have specific rights regarding your personal data. For full details on how we collect, use, store, and protect your information — including disclosures for California residents under the CCPA and for applicants under the GDPR — please review our applicant privacy notice.