Hiring: Associate Director, Global Regulatory Advertising and Promotion Company: Moderna Location: Cambridge, MA Job Posted Time: 2026-09-10 14:13:48 Target Skills & Keywords : Regulatory Compliance About the job Experience: •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. •Global regulatory knowledge (EMA, Health Canada, UK etc.) is a plus. •Comprehensive expertise in US and global regulatory frameworks for advertising and promotion. Required Skills: •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) working closely with Marketing, Medical, Legal, and Compliance teams to develop impactful material that aligns with regulatory expectations. •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. Qualifications: •Bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline). •Advanced degree (PharmD, JD, or Master’s in Regulatory Affairs) preferred. Compensation: •$142,500 - $256,500 / year •Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!