Sumitomo Pharma is hiring: Director, Regulatory Advertising & Promotion in Jacks

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. 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. 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 applicable materials to regulatory agencies.Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA.Serve as internal regulatory expert on FDA regulations, guidance and enforcement trends governing the promotion of prescription therapies.May be responsible for creating and reviewing SOPs and department operating procedures.Manage and Develop TalentMay train/mentor junior staff and/or oversee external consultants.Key Core CompetenciesStrong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills with the ability to influence others, internally and externally, in a positive and effective mannerUnquestionable ethics, professional integrity, and personal values consistent with the SMPA valuesAbility to work in a diverse environmentAbility to prioritize tasks and work across locations and time zonesDemonstrated ability to adapt to changing priorities and work effectively in a matrix organizationDemonstrated track record of leading promotional copy review and approval team and of successful interactions with OPDP staff and managementSense of urgency and perseverance to achieve resultsCapable of effectively negotiating with others while maintaining composureAbility to learn new therapeutic areas when necessaryAbility to make complex decisions and willingness to defend difficult positionsComfortable presenting to all levels of the organization including Senior ManagementEducation and Experience8 – 12 years experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory advertising & promotion.Advanced degree preferred (preferably in a scientific discipline)The base salary range for this role is $187,520 - $234,400. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.Confidential Data : All information (written, verbal, electronic, etc.) For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.Our MissionTo broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwideOur VisionFor Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas #J-18808-Ljbffr