Director, Regulatory Affairs, Commercial (Advertising & Promotion)

Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are important pain targets. We are seeking a Director, Regulatory affairs, Commercial (Advertising & Promotion), to join our Regulatory Affairs team. 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 documentsProvide 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 outcomesDevelop and establish strong internal cross-functional relationships with the Commercial, Medical Affairs, Legal, Compliance, Corporate Affairs, and Development to foster open communication, collaboration, and teamworkContinually monitors and evaluates the regulatory environment, interprets new regulations, guidance documents, enforcement activities and trends for potential impact on the business and companyMaintain in-depth understanding of clinical trial design and interpretation of clinical data and communicate complex issues clearly and concisely Establishes and maintains 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 efficienciesAct 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 anyOther duties as assigned

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