Manager, US Medical Ad/Promo Regulatory Review

Objectives

The Manager, US Medical Ad/Promo Regulatory serves as an internal resource on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. Manages at least one (1) individual Brand or one (1) component of a therapeutic area (e.g., consumer or professional promotion) for multiple brands; supports other Ad/Promo Regulatory team members. Independently provides regulatory guidance and expertise to promotional review team on the assigned products(s) of responsibility and identifies regulatory requirements and data needed to ensure claims are supported for products. During the developmental stage, may be asked to provide promotional regulatory guidance for creation of the product labeling to enhance marketing of Takeda products.

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, with some oversight from manager.
• Researches and evaluates advertisement and promotional precedents for marketed products to assist with providing well-supported and clear guidance to key stakeholders.
• Evaluates materials to ensure compliance with FDA regulations, guidance, corporate standards and policies and business objectives.
• Assesses the impact of proposed labeling changes for a particular product and its potential impact on advertising and promotional materials.
• May act as chair of promotional review meetings.
• Assists Commercial with the planning and prioritization of proposed promotional and disease state materials.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for given claims for therapeutic area(s).
• Understands broad concepts within regulatory affairs; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies; demonstrates increasing independence beyond single therapeutic area.
• 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.
• Other duties as assigned.

Education, Experience, Knowledge and Skills

• Bachelor's Degree in life science or equivalent.
• Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• Minimum of 3 years' experience in drug, biologic or device Regulatory Affairs or related field, including a minimum of 1 year experience specific to Regulatory Affairs – Advertising and Promotion.
• Knowledge of FDA regulations.
• Ability to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
• Ability to 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.
• Understanding of scientific principles and regulatory/quality systems relevant to drug development.
• 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.
• Demonstrates problem-solving ability and generates alternative solutions prior to elevation of issues to manager.
• Model leaders at all levels daily.

Licenses/Certifications

None required. Regulatory Affairs Certification (RAC) desirable.

Travel Requirements

Travel to meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately up to 20% travel.