Associate Director, US Advertising & Promotion Regulatory Review

About the role

As Associate Director, US Advertising & Promotion Regulatory Review on the US Medical team, you will serve as the 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 complex products or therapeutic area products to ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds.

• Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
• Provide regulatory strategic oversight for at least one complex product or therapeutic area/multiple products to ensure regulatory compliance of promotional materials.
• Interpret complex issues in relation to regulatory requirements and promotional strategy.
• Mentor and develop staff; supervise, train, and provide technical and regulatory guidance.
• Chair promotional review meetings and assist Commercial in planning and prioritization of proposed promotional and disease state materials.
• Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance; execute and approve key Commercial campaigns.
• Provide expert guidance to evaluate and mitigate potential risk.
• 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.
• Provide product development and label development strategies to ensure promotional claims can be supported.
• Manage individuals, including mentoring, performance management, and staffing decisions.
• 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/or guidance documents.
• Serve as a primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and other interactions regarding the use of claims for assigned business unit/therapeutic areas.

• Bachelor’s Degree in life science or equivalent required.
• Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• Minimum of 5 years’ experience in drug, biologic and/or device Regulatory Affairs or related field, including at least 3 years specifically in Regulatory Affairs – Advertising and Promotion.
• Knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences.
• Experience in Regulatory Affairs promotion and advertising; experience managing major regulatory filings (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
• Ability to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials; representation on global regulatory and labeling teams.
• Leadership experience providing regulatory advice and recommendations on complex regulatory issues.
• Regulatory Affairs Certification (RAC) desirable.

Location: Massachusetts – Virtual (U.S.)

Base Salary Range: $ – $ (annually)

U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan with 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. U.S. employees can accrue up to 80 hours of sick time and up to 120 hours of paid vacation.

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.