Manager, Regulatory Advertising & Promotion

Regulatory Advertising & Promotion Policy (RAPP), US Regulatory Affairs We operate as a team with a leadership mindset and foster an inclusive environment where team members’ individual strengths are recognized and given visibility and there are expanding opportunities to develop a breadth and depth of regulatory expertise and leadership skills. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… • Provide Regulatory advice to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the review and development of advertising and promotion for the US market in accordance with business goals and objectives, FDA regulation, PhRMA guidelines and company policy • Serve as internal expert on FDA regulations governing the promotion of assigned products • Act as a credible, influential, respected spokesperson during interactions with the Office of Prescription Drug Promotion (OPDP) and/or the Advertising and Promotional Labeling Branch (APLB) for assigned products • Manage interaction with OPDP/APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP/APLB staff • Participate in company working groups on advertising and promotion standards and guidelines • Assist on the development of US labeling to ensure support for anticipated promotional messages and claims • Understanding of labeling for assigned GSK and competitor products • Competitively position promotional materials that comply with applicable FDA regulations, policies and guidance • Demonstrate leadership as the Regulatory reviewer on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate • Monitor OPDP/APLB research, guidance and enforcement activities, assess impact and communicate learnings to stakeholders • Influential member of multiple cross-functional US Pharma and R&D teams. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.