Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion

Syndax Pharmaceuticals is looking for a Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion to lead labeling activities and the review of promotional materials in commercial regulatory affairs at Syndax for the company’s 2 marketed FDA approved products in acute leukemia and chronic GVHD. The position reports to the Executive Director, Commercial Regulatory Affairs. The Director will lead and provide strategic input and oversight of regulatory labeling activities including labeling strategy for future indications of the lead company asset. The Director will lead the Labeling Working Group (LWG) meeting to develop an optimal Target Product Label (TPL), and U.S. Product Information (USPI) strategy and EU SmPC when applicable. This role will represent RA Labeling as the functional representative across the organizational levels relevant to assigned products and/or other activities. This role may include future responsibilities for managing, overseeing, reviewing, and approving the work of more junior staff related to labeling activities. This role will help to serve regulatory strategy in managing complex labeling negotiations with regulatory health authorities for future label expansion. This role also serves the as a central point of contact and expert for global Regulatory teams in interpreting content and messaging of Company Core Data Sheets (CCDSs) and USPIs. The Director will act as a key advisor to cross-functional partners, stakeholders, and teams and lead impact assessments on major labeling issues. This role will assist with cross-functional meetings involved in the governance and decision-making of regulatory labeling with senior leadership in Labe Committee (LC) and when applicable strategic Task Forces for critical labeling workstreams. This role will be responsible for training cross-functional partners and teams on labeling processes, policies, procedures, standards, etc. The Director will engage business partners for planning and implementation on issues pertaining to product promotion and will participate in the review and approval of promotional materials under the guidance of the Executive Director, Commercial Regulatory as assigned. This role will include regulatory review of promotional materials for 2 marketed products with opportunities to further refine regulatory review skills in complex areas. He or she will provide the regulatory aspects for the review and approval process for product promotion materials working collaboratively with respective legal, medical and commercial colleagues. This role involves interacting with commercial, medical and legal on a regular basis. The candidate will have direct influence on the decision-making processes within the Promotional Review Committee (PRC) within the scope of the advertising and promotion of assigned marketed products and commercial compliance for Syndax. Key Responsibilities: Develops and accountable for end-to-end labeling processes, activities, and respective SOPs for lifecycle development of CCDS, USPI Independently authors new/revised TPL, TPP, CCDS, USPI and when applicable EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation Leads Labeling cross-functional working group (LWG) and interacts with cross-functional senior leadership to resolve complex issues, including leading and contributing to cross-functional initiatives by providing expertise in labeling best practices Facilitates the process to obtai