Associate Director, US Advertising & Promotion Regulatory Review

Takeda•USA - MA - Virtual, MA

23h•$154,400 - $242,550•Remote

About The Position

Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review where you will be working on the US Medical team. In this role, you will be empowered to serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will contribute to Takeda’s mission by providing regulatory strategic oversight for complex products or therapeutic area products to help ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds.

Requirements

Bachelor’s Degree in life science or equivalent required.
Minimum of 5 years’ experience in drug, biologic and/or device Regulatory Affairs or related field.
Minimum of 3 years’ experience specific to 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 filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams.
Provide leadership related to issues of importance.
Provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights.

Nice To Haves

Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
Regulatory Affairs Certification (RAC) desirable

Responsibilities

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 (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds.
Interpret complex issues in relation to regulatory requirements and promotional strategy.
Mentor and develop staff.
Supervise, train and provide technical and regulatory guidance to staff.
Be the chair of promotional review meetings and assist Commercial with the 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 help 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.
May provide management of individuals including mentoring, performance management, and staffing decisions.
Identifies and proposes 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.
Be a primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding the use of claims for assigned business unit/therapeutic areas.