Director, US Medical Advertising/Promotion Regulatory Review

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES: Leads the Promotional Review Team (PRT) process from a US Advertising & Promotion (Ad/Promo) Regulatory perspective for at least one (1) business unit / therapeutic area. Leads the Ad/Promo Regulatory Team for assigned business unit/therapeutic area by providing strategic guidance on proposed promotional strategies, campaigns, materials by evaluating feasibility, risk assessment and ensuring compliance with regulatory requirements, internal policies, and procedures. Collaborates with US Ad/Promo Regulatory Senior Leadership in the development, integration, and full implementation of internal policies. Provides direct supervision of individuals within their Ad/Promo Regulatory Team for assigned business unit/area including mentoring, performance management, skills development and staffing decisions. This role is responsible for ensuring a unified Ad/Promo Regulatory position for the assigned business unit / therapeutic area. Leads and/or negotiates topics with FDA’s Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB), as needed. Collaborates with the International Regulatory Ad/Promo Review Team Leadership for global products / strategies (e.g., global press releases or campaigns), as needed. ACCOUNTABILITIES: The Director, US Medical Ad/Promo Regulatory serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. Provides overall Ad/Promo Regulatory leadership, strategic guidance, and expert regulatory evaluation of proposed critical promotional materials for products within assigned business unit/therapeutic area. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims that are consistent with product labeling. Provides consistent, well-supported, and clear guidance to key stakeholders. Serves as the chair of at least one (1) strategic-level promotional review meeting and assists Commercial with the strategic planning and prioritization of proposed promotional and disease state campaigns. Provides expert guidance related to Regulatory strategy to senior Commercial leadership and key stakeholders during early development of projects to ensure promotional goals can be achieved (e.g., target product profile; clinical trial recruitment materials). Participates in promotional review escalation meetings, as needed. Serves as primary Ad/Promo Regulatory lead for team members during initial PRT and Global Regulatory Affairs (including Labeling) elevations. Maintains a thorough understanding of OPDP and/or APLB requirements, as well as a keen awareness of FDA enforcement trends. Represents US Ad/Promo Regulatory on organizational or business unit initiatives (e.g., digital medial council, FDA payer initiatives, revisions to promotional standards). Manages direct reports to ensure consistent review standards within the electronic approval system (EAS) system are upheld, and business trends are evaluated and addressed. Supports metrics to measure and track effectiveness and efficiency of the promotional review process; provides recommendations for process improvements to address issues, gains agreement of process improvements from key stakeholders, and helps implement agreed-upon process improvements. 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). Participates in the review of comments to FDA’s Docket regarding Federal Register Notices that may impact the organization’s promotion of commercial products. 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 area. Understands broad concepts within regulatory affairs and potential implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies. Provides 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. Other duties as assigned. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred. Ideal candidate has a minimum of 7 years’ experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 4 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. Extensive 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. Provide leadership related to issues of critical importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Understands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed. Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion including major global codes of practice and regulations. Has a thorough knowledge of historical enforcement actions and is readily able to use this when offering recommendations to stakeholders. Excellent oral and written skills, timeline responsibilities, negotiations skills. Works well with others, especially on a cross-functional team, direct reports and senior leadership. Prior leadership of individuals/team preferred. Demonstrated leadership skills. Ability to effectively manage and bring working teams together for common objectives. Models leadership at all levels daily. LICENSES/CERTIFICATIONS: None required. Regulatory Affairs Certification (RAC) desirable. TRAVEL REQUIREMENTS: Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately up to 25% tra