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Job Description
About the role:
Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will also provide regulatory strategic oversight for at least one complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products and compounds.
Objectives:
Understand and interpret complex issues in relation to regulatory requirements and promotional strategy.
Mentor and help develop staff. Assist with training and sharing technical and regulatory guidance to staff.
Serve as the chair of promotional review meetings and assist Commercial with the planning and prioritization of proposed promotional and disease state materials.
May present to senior management, and present regulatory topics to cross-functional teams.
May serve as primary liaison with OPDP and APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products.
Ensure review standards within the electronic approval system (EAS) are upheld, and business needs are assessed and addressed.
Support metrics to measure and track the effectiveness and efficiency of the promotional review process and provide recommendations for process improvements to address potential issues.
Position Accountabilities:
Collaborate with colleagues in Regulatory Affairs, Medical, Legal, Commercial, and Compliance organizations and applies Regulatory knowledge to ensure promotional and non-promotional material development is accomplished following internal processes and standards.
Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify regulatory issues. Offer creative solutions and strategies, including risk mitigation strategies.
Evaluate regulatory risks and make recommendations relative to the promotional strategy.
May provide management of individuals including mentoring, performance management, and staffing decisions. Mentor and develop staff. Identify and propose solutions to management for any resource gaps for brand responsibilities.
Present to senior management and cross-functional teams regarding shared insights from FDA advisory comments, recent enforcement actions, and guidance documents.
Collaborate 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 responsibilities as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor's Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
You have a minimum of 4 years' experience in drug, biologic or device Regulatory Affairs or related field, including a minimum of 2 years' experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered.
Knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products.
Experience managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters)…