Director, Regulatory Affairs, CMC

Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE https://www.nasdaq.com/market-activity/stocks/xene) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline https://xenon-pharma.com/pipeline to address indications with high unmet medical need, including epilepsy and depression. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b X-TOLE study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In November 2025, we announced the completion of patient enrollment in our Phase 3 X-TOLE2 study, and topline data are anticipated in March 2026. We also have multiple Phase 3 azetukalner clinical trials in major depressive disorder (MDD) and bipolar depression (BPD) underway, based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. We have recently initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, in pain. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. About the Role: We are seeking a Director, Regulatory, CMC to join our team. This position reports to the Executive Director, Regulatory Affairs, CMC and will be based out of Vancouver, BC, Canada. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week. RESPONSIBILITIES: - Propose and implement global CMC regulatory strategies and provide regulatory guidance to cross-functional teams and functional areas for assigned programs from the pre-clinical stage through approval and life-cycle management, with potential focus on late stage/commercial programs. - Proactively and effectively communicate risks and potential mitigations to teams and key stakeholders in a timely manner. - Assess and communicate regulatory requirements to ensure all CMC activities are in compliance with applicable regulations and guidelines. - Manage and ensure compliance with all reporting requirements, including annual and periodic reports. - Plan, manage, author, review, and obtain stakeholder alignment to facilitate the submission of high-quality CMC sections of regulatory submissions to support initial INDs/CTAs, marketing applications, supplements and variations. - Work closely with Technical Writers to ensure CMC sections of regulatory submissions are accurate and compliant. - Lead multidisciplinary teams preparing responses to Regulatory Agency questions. - Effectively plan, organize and contribute to formal meetings with global regulatory agencies to ensure alignment on CMC strategies, resolve CMC issues and oversee proactive interactions for initial INDs/CTAs, marketing registration applications, supplements and variations. - Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of regulatory applications. - Provide regulatory support for relevant quality systems such as change control, deviation t, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation. - Develop, review, and maintain Regulatory CMC departmental policies and SOPs. - Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines, and other international regulatory regulations and guidelines, as needed to support global clinical and commercial programs. - Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices. - Some travel may be required. - Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans - 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. QUALIFICATIONS: - A Bachelor’s, Master’s, or PhD in a scientific, medical, or regulatory discipline and 10+ years of management experience or combination of degrees and experience of progressively responsible Regulatory Affairs in a pharmaceutical, biotechnology, or related environment required. - Experience in managing commercial programs marketed in US, EU, Canada and other major markets - Experience in rare disease indications and/or orphan drug development is desirable. - Demonstrated, hands-on experience, managing and preparing regulatory submissions including INDs/CTAs and/or marketing applications, supplements and variations in US and other major markets. - Demonstrated track record of successful global regulatory submissions and strategies. - Prior Regulatory Agency liaison experience is desirable. - Strong competency in understanding global regulatory requirements and the emerging regulatory landscape. - Detail oriented with excellent written and verbal communication and presentation skills. - Ability to work independently and collaboratively, as required, with a high degree of flexibility in a fast-paced, team environment consisting of internal and external team members. - Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs. - Experience with Veeva RIM is desirable. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.