Director, Regulatory Advertising and Promotion Policy

• 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, PhRMA guidelines and company policy • As an internal expert on FDA regulations governing promotion, maintain awareness of evolving regulations and interpretations, advisory comments, enforcement letters and policy issues, and communicate relevant information appropriately to stakeholders • 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, Regulatory Matrix Teams and R&D teams with senior membership • Identify continuous improvement opportunities • Participate in company working groups that focus on advertising and promotion standards and guidelines • Serve as regulatory advertising and promotion lead on cross-functional matrix teams supporting early pipeline assets and pre-launch products for future promotional impact. We are looking for professionals with these required skills to achieve our goals: • 5 or more years of regulatory experience in the development of Pharmaceutical advertising and promotion for the US market (for major company assets) • Prior work experience interacting with OPDP and/or APLB reviewers • Experience working on pre-launch activities and launch promotional campaigns • Experience facilitating groups of individuals to work together on creating solutions While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).