Associate Director, Global Regulatory Advertising and Promotion

The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across various communication channels. This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic regulatory guidance on advertising and promotional activities. The ideal candidate will have expertise in FDA regulations, OPDP (Office of Prescription Drug Promotion)/Advertising and Promotional Labeling Branch (APLB) guidance, and industry best practices.

Responsibilities

Review and approve promotional materials, corporate communications, and disease awareness campaigns to ensure compliance with FDA and other applicable regulatory requirements; Guide promotional strategy as the Regulatory Ad Promo representative during early stages of product development; Maintain up-to-date knowledge of regulatory requirements, enforcement trends, and industry best practices; Lead discussions for assigned products during the Promotional Material Review Team (PMRT) and Medical Review Committee (MRC); Support interactions with the FDA’s Advertising and Promotional Labeling Branch (APLB) and other regulatory authorities as needed; Prepare regulatory submissions for promotional materials, including 2253 filings and advisory comments requests; Address regulatory queries from health authorities regarding promotional and advertising content; Develop and deliver training programs on promotional regulations for internal stakeholders; Help refine internal SOPs, best practices, and review processes for advertising and promotion compliance; Monitor and analyze enforcement actions and industry trends to proactively mitigate regulatory risks

Requirements

Bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline); Minimum 5 years of experience in Regulatory Affairs, with at least 2 years focused on advertising and promotion in the pharmaceutical, biotech, or medical device industry; Strong knowledge of applicable regulations and enforcement trends; Prior experience working with cross-functional review committees in a regulated environment; Deep understanding of US and global regulatory frameworks for advertising and promotion; Excellent ability to interpret and apply regulatory guidelines and requirements in a business-focused, solutions-oriented manner; Strong written and verbal communication skills, with experience in preparing regulatory documentation; Ability to work cross-functionally and manage multiple projects in a fast-paced environment; Strong attention to detail and problem-solving skills

Nice to have

Advanced degree (PharmD, JD, or Master’s in Regulatory Affairs); Global regulatory knowledge (EMA, Health Canada, UK etc.); Familiarity with digital and social media promotional compliance; Experience in infectious diseases, oncology, rare diseases, and/or vaccines

Benefits

Competitive healthcare, plus voluntary benefit programs; A holistic approach to well-being, with access to fitness, mindfulness, and mental health support; Family planning benefits, including fertility, adoption, and surrogacy support; Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown; Savings and investments to help you plan for the future; Location-specific perks and extras; Eligibility for an annual discretionary bonus, other incentive compensation, or equity award