Senior Manager, US Medical Ad/Promo Regulatory Review Expert
7 days ago
We are seeking a highly skilled Senior Manager, US Medical Ad/Promo Regulatory Review to join our team at Takeda. As an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products, you will provide regulatory strategic oversight for at least one complex product or therapeutic area/multiple products to ensure regulatory compliance of promotional materials generated for assigned US products and compounds.
Key Responsibilities- 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.
- Bachelor's Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
- 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.
- 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) preferred.
- Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
- Deal with issues of importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance.
- Understand the phases, processes and techniques used within a clinical development environment, and can contribute to clinical study design discussions.
- Maintain current knowledge of applicable government regulations, particularly those related to advertising and promotion, including important global codes of practice and regulations. Have knowledge of historical enforcement actions and can use this when offering recommendations to stakeholders.
- Excellent oral and written skills, timeline responsibilities, negotiations skills. Work well with others, especially on a cross-functional team, direct reports and senior leadership.
Takeda is proud to offer a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
About TakedaTakeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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Lexington, Massachusetts, United States Takeda Full timeAbout the RoleTakeda is seeking a highly skilled Senior Manager, US Medical Ad/Promo Regulatory Review to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with FDA regulations and guidelines for the promotion of prescription drug and biologic products.Key ResponsibilitiesCollaborate with...
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