Director, Regulatory Affairs, CMC

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, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting, and continue to advance an early-stage pipeline of novel therapeutic candidates. In 2025, we initiated Phase 1 trials for XEN1701 (targeting Nav1.7) and XEN1120 (targeting Kv7). Nav1.7 and Kv7 are important pain targets, and data from these Phase 1 studies are expected in 2026 to support Phase 2 proof-of-concept studies in acute 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 Boston, MA, USA in our Needham office. 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. ... (truncated, view full listing at source)