Director, Regulatory Advertising & Promotion Policy

Our Global Regulatory Affairs organization plays a critical role in enabling delivery of innovative biopharmaceuticals to patients. Regulatory Advertising & Promotion Policy (RAPP), US Regulatory Affairs We are trusted Regulatory advertising and promotional experts who are accountable for making sound regulatory decisions that enable the organization to deliver high quality... promotional materials and executions that educate our patients and customers and drive performance. 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. The Role - Director, Regulatory Advertising & Promotion Policy As the Director, Regulatory Advertising & Promotion, you will be responsible for leading assigned products providing sound regulatory advice for advertising and promotion of prescription drug products and biologics that minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with applicable FDA regulations and GSK policy. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following Provide strategic and operational leadership to Marketing Brand Teams, Legal, Medical Affairs and Clinical in the development of advertising and promotion for the US market (for major company assets) in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy Internal expert on FDA regulations governing the promotion of assigned products Establish and nurture a productive, transparent relationship with OPDP and/or APLB to achieve successful and timely review of advisory submissions and effective resolution of regulatory actions Advise on the development of US labeling to ensure support for anticipated promotional messages and claims In-depth understanding of labeling for assigned GSK and competitor products and the subsequent translation of that knowledge into the development of promotional materials Competitively position promotional materials that comply with applicable FDA and corporate regulations, policies and guidance Influential member of multiple cross-functional US Pharma and R&D teams with senior membership Identify continuous improvement opportunities Maintain a deep and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry and communicate relevant information appropriately to stakeholders Participate in company working groups that focus on advertising and promotion standards and guidelines Provide input on promotional implications of proposed clinical study designs, as appropriate Why you?