Director Regulatory Affairs Commercial (Advertising & Promotion)

The Director will be responsible for strategic regulatory advice and direction for marketed products and development compounds in alignment with the overarching regulatory and brand strategy. The Director will report to the VP of Commercial Regulatory Affairs. This position reports to the Vice President, Regulatory Affairs, Commercial and will be based out of Boston, MA, USA in our Needham office. This is a Hybrid position requiring a minimum of two onsite days per week. Provide strategic regulatory advice, review, and decisions for product promotion, disease state education, pipeline, and Medical materials for alignment with applicable FDA regulations and guidance documents Provide strategic regulatory support to the business by generating innovative solutions and effective problem‑solving aligned with the company’s guiding principles in order to achieve desired outcomes Develop and establish strong internal cross‑functional relationships with the Commercial, Medical Affairs, Legal, Compliance, Corporate Affairs, and Development to foster open communication, collaboration, and teamwork Continually monitor and evaluate the regulatory environment, interpret new regulations, guidance documents, enforcement activities and trends for potential impact on the business and company Maintain in-depth understanding of clinical trial design and interpretation of clinical data and communicate complex issues clearly and concisely Establish and maintain a relationship with the Office of Prescription Drug Promotion (OPDP) at FDA Provide appropriate oversight of promotional material review and ensure on‑time and accurate submission of applicable materials to FDA Assist with training employees at Xenon and in developing and improving process efficiencies Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any Other duties as assigned

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