Xenon Seven

Xenon Seven

Senior Manager, Regulatory Affairs, Operations

Boston · Senior

Sponsorship not specifiedDetected 97 days ago
RESTExcelClinical TrialsFDA RegulatoryResearchCommunicationMicrosoft OfficeRegulatory Affairs

About the role

  • The Senior Manager, Regulatory Affairs Operations is instrumental in supporting global regulatory submissions across Xenon's development portfolio.
  • The position operates in a fast‑paced environment and requires strong operational judgment, clear written and verbal communication, and effective vendor oversight.
  • Additionally, they should possess experience managing the lifecycle of regulatory submissions, including INDs, international clinical trial applications (CTAs), and marketing applications in eCTD format.

Responsibilities

  • 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.
  • 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.
  • Develop and maintain document templates (e.g., eCTD content and structure per ICH guidelines) and internal style guides for documents to be submitted in regulatory filings.
  • Consults with other groups to ensure consistency in processes and procedures for documents destined for regulatory submissions.

Requirements

  • A minimum of 5 years' management level experience in a pharma or biotech environment.
  • Expert proficiency in MS Word, PowerPoint, Excel, and Adobe Acrobat.
  • Hands-on experience in the process of generating, reviewing and formatting documentation for worldwide regulatory submissions.
  • Familiarity with eCTD publishing software.
  • Must be organized, highly collaborative, and able to problem-solve and anticipate departmental needs.
  • Ability to work successfully in cross-functional teams.
  • Some international travel may be required
  • Contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support the activities.
  • Bachelor's degree in a scientific discipline with 8+ years of regulatory documentation and operations experience in a pharmaceutical, biotechnology or contract research organization (CRO), including experience in project coordination and document management systems and processes. A combination of degrees and experience will be considered.
  • Experience with pharmaceutical regulatory submissions (specifically, eCTD) and supporting regulatory filings, such as annual reports, IND/CTA or NDA/MAA.
  • Understanding of the drug development process, FDA/EMA regulations and ICH guidance.
  • Understanding of best practices for regulatory filing planning; ability to create and manage an accessible and reliable system for regulatory document retrieval and archiving.
  • Demonstrate strong initiative and drive. Must be organized, highly collaborative, and able to problem-solve and anticipate departmental needs.
  • Ability to work successfully in cross-functional teams. Strong interpersonal and communication skills.

Compensation

  • Experience with pharmaceutical regulatory submissions (specifically, eCTD) and supporting regulatory filings, such as annual reports, IND/CTA or NDA/MAA.

Benefits

  • Updates internal processes to ensure compliance with health authority requirements and expectations.

Company info

  • 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.
  • 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.
  • 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.
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