Job Description
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director, Regulatory Advertising & Promotion . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regulatory reviewer for assigned products. This position is responsible for providing strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with the business needs and objectives. This position may train/mentor junior staff and/or oversee external consultants. This position works with a high level of autonomy and requires limited coaching and mentoring. Advertising & Promotion Review Activities Review and approve materials that comply with relevant external advertising & promotional regulations or codes of practice (e.g., FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding principles. Align with regulatory colleagues on strategies to optimize the commercial success of products for clinical trials, labeling, etc. Develop and maintain productive working relationships with colleagues and vendors contributing to development, review, and approval of promotional materials, e.g. Marketing and their Agencies, Legal, Compliance, and Medical Affairs. Provide appropriate oversight of promotional material review and ensure on-time and accurate submission of applica
