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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. 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. 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: The Senior Manager, Regulatory Affairs Operations is instrumental in supporting global regulatory submissions across Xenon’s development portfolio. This role is responsible for submission operations, publishing strategy, and lifecycle management, partnering closely with Regulatory Program Leads and cross-functional teams to ensure timely, compliant global filings. The position operates in a fast‑paced environment and requires strong operational judgment, clear written and verbal communication, and effective vendor oversight. The ideal candidate should demonstrate deep expertise in RIM systems, and a solid understanding of FDA and EMA regulatory requirements. Additionally, they should possess experience managing the lifecycle of regulatory submissions, including INDs, international clinical trial applications (CTAs), and marketing applications in eCTD format. This position reports to the Director, Regulatory Affairs, Operations, and is based out of Xenon USA’s Needham, MA, USA office. We will consider other jurisdictions for exceptional candidates. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week. RESPONSIBILITIES: - Regulatory Information Management (RIM) system expertise: - Submission/registration management - eCTD & publishing integration - Lifecycle management - Metadata & data governance - Workflow and process configuration - Maintain processes for regulatory submission document formatting, working with external publishing vendors, and transmittal to regulatory agencies. - Manage contractual relationships and workstreams with external publishing vendors for building submissions in the eCTD structure and filing the output via the Electronic Submissions Gateway (ESG). - Serve as the unblinded regulatory person for the sig