[Hiring] Senior Manager, US Medical Ad/Promo Regulatory Review @Takeda

Role Description

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.

• 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.

Qualifications

• 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.
• Excellent oral and written skills, timeline responsibilities, negotiations skills.
• Prior leadership of individuals/team not required, but preferred.

Requirements

• 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, providing regulatory advice and decisions 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.
• Ability to effectively manage and bring working teams together for common objectives.

Benefits

• U.S. Base Salary Range: $137,000.00 - $215,270.00
• Equitable pay for all employees.
• Transparency with pay practices.

Company Description

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.