Senior Manager, Regulatory Affairs, Operations

Senior Manager, Regulatory Affairs, Operations 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. 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 sign-off (Covering Letter/FDA form 1571) and manage the submission of expedited safety reports (i.e., SUSARs) to the FDA. In addition, performing periodic review of safety submission trackers for submission compliance with regulatory timeline requirements. - Support regulatory program leads and project teams in creating timelines for activities related to the preparation and publishing of regulatory submissions. - Maintain the Xenon regulatory submission calendar and other internal trackers, provide status updates, and ensuring that stakeholders have the most recent versions for their reference. - Provide advice from an operation’s perspective across all projects on the acceptability of regulatory submission and publishing timelines in regard to coordination of internal and external resources and vendors. - Contribute to internal process improvements that impact on Regulatory department operational functions. - Communicate current and emerging publishing and routine reporting regulatory requirements to stakeholder groups within Xenon. - Advise ... (truncated, view full listing at source)