A Brief Overview Lead the team within Global Regulatory Affairs that provides strategic regulatory expertise and guidance to global internal leaders and stakeholders regarding the marketing of products including review of advertising, promotional and other related materials to ensure compliance with applicable regulations and guidance documents. The individual will oversee or represent regulatory on global and certain regional PRC (Promotional Review Committee) teams, SRC (Scientific Review Committee) teams and must possess a thorough knowledge of regulations for medical affairs activities, advertisement and promotional compliance governing drugs, device, cosmetic, and combination products and the ability to translate regulatory requirements into decision-ready guidance for senior stakeholders. What You Will Do Leadership Provide global leadership for and manage regulatory aspects of the copy review / approval process for promotional materials and ensure compliance of promotional materials with laws, including FDA and notified body regulations and published guidance documents. Cross-Functional Leadership Work closely with R&D project teams to advise on projects and advise on new products, indications and launches. Bachelor's Degree In Scientific or Health Discipline 12+ years Of pharmaceutical/medical device industry experience and minimum of 5 years as a regulatory affairs reviewer of advertising and promotional materials 5+ years Must have a proven track record of managing direct reports, successful internal stakeholder management and collaboration, communication, and interacting with FDA and OPDP Preferred Qualifications Master's Degree Or Higher Education Technical & Functional Skills Advanced skills with all MS Office applications and comfort with a variety of digital communication tools and AV equipment Experience with social media platforms and their use in the context of drug and device advertising, promotion, and labeling Strong attention to detail.
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