- The Associate Director, US Ad/Promo Regulatory Review serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
- Capable of providing regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds.
- Understands and interprets complex issues in relation to regulatory requirements and promotional strategy.
- Able to mentor and develop staff. Supervises, trains and provides technical and regulatory guidance to staff.
- Serves as the chair of promotional review meetings and assists Commercial with the planning and prioritization of proposed promotional and disease state materials.
- Collaborates with Regulatory Affairs, Medical, Legal, Commercial, and Compliance, executes and approves key Commercial campaigns. Provides expert guidance to help evaluate and mitigate potential risk.
- Serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The role is responsible for thoroughly reviewing and assessing proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
- Understands broad concepts within Regulatory Affairs and potential implications across the organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
- Provides product development and label development strategies, as needed, to ensure promotional claims can be supported.
- May provide direct supervision of individuals including mentoring, performance management, and staffing decisions. Identifies and proposes solutions to management for any resource gaps for brand responsibilities.
- Presents to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
- Serves as primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding the use of claims for assigned business unit/therapeutic areas.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
- Ideal candidate has a minimum of 5 years’ experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years’ experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered.
- Extensive knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences.
- Previous experience in Regulatory Affairs promotion and advertising; experience in managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
- Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams.