Assoc Director Us Ad/promo Regulatory Review Gi usbu

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Assoc Director, US Ad/Promo Regulatory Review, GI (USBU)

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. Serves as primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products. Ensures consistent review standards within the electronic approval system (EAS) are upheld, and business needs are assessed and addressed. Supports metrics to measure and track the effectiveness and efficiency of the promotional review process and provides recommendations for process improvements to address potential issues. Accountabilities: 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. Leads internal Ad/Promo project work streams (e.g., best practice documents) and is an active participant at team staff meetings (e.g., present FDA guidance/enforcement letters). Collaborates with the International Regulatory Ad/Promo review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns). Other duties as assigned.

Company info

Takeda Pharmaceutical Company Limited.
One Takeda Parkway
Deerfield
Illinois
United States 60015
Website : https://www.takeda.com