Regulatory Affairs, Advertising and Promotion, EU

The Advertising and Promotion Regulatory Affairs role will provide strategic regulatory expertise, and guidance to internal and external stakeholders related to the review of scientific information, advertising, promotional and other related materials for assigned products to ensure compliance with applicable regulations and guidance documents. The individual will represent regulatory on the PRC (Promotional Review Committee) team for assigned products and must possess a thorough knowledge of regulations for advisement and promotional compliance, governing drugs, device and combination products. Regulatory Awareness • Maintain current awareness of evolving EU MDR and FDA regulations and interpretations, enforcement letters and policy issues affecting the pharmaceutical and medical device industries. Monitoring the regulatory compliance trends and competitive materials in the aesthetic industry • Regularly monitor the regulatory compliance trends in the aesthetic industry, interpret new regulations, guidance documents and enforcement actions. Technical & Functional Skills • Strong knowledge of EU MDR and FDA regulations and guidance pertaining to drug and device advertising, promotion, and labeling • Proficiency in Microsoft Outlook, Excel, PowerPoint and Word and comfort with large variety of online meeting tools and AV equipment • Excellent written, oral and interpersonal communication skills • Demonstrated history of teamwork and cross functional collaboration • Demonstrated history of creative problem solving and risk analysis related to promotional materials in the drug and medical device industry