---
title: 'Senior Director, Regulatory Affairs, CMC at Xenon Pharmaceuticals'
canonical: 'https://feeny.ai/job/senior-director-regulatory-affairs-cmc-xenon-pharmaceuticals-boston-81ef8453d6fy'
type: 'job'
last_seen: '2026-10-29'
---

# Senior Director, Regulatory Affairs, CMC at Xenon Pharmaceuticals

- **Company:** Xenon Pharmaceuticals
- **Location:** Boston, MA
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-10-27
- **Last confirmed live:** 2026-10-29
- **Apply:** https://jobs.ashbyhq.com/xenon/05577cd6-9942-429c-8ffd-327b2f648a8d

## Job description

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 submitted 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 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for 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: This position reports to the Executive Director, Regulatory Affairs, CMC, and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week.

## RESPONSIBILITIES:

- Provide strategic regulatory CMC leadership for one or more major development or commercial assets and serve as a senior regulatory CMC advisor to cross-functional teams.
- Proactively and effectively communicate risks and potential mitigations to teams and key stakeholders in a timely manner.
- 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 marketing applications, supplements and variations.
- Partner closely with CMC, Operations, Quality, Supply Chain, and Program Management to advance programs and ensure regulatory readiness. 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 late-stage or commercial programs, marketing registration applications, supplements and variations.
- Provide regulatory support for relevant quality systems such as change control, deviation, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
- Contribute to departmental objective and continuous improvement initiatives within Regulatory Affairs CMC.
- Interpret emerging global regulatory requirements and provide strategic guidance regarding potential impact on development and commercial programs.
- Aid in recruitment, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
- 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.
- Some travel may be required.
- Other duties as assigned.

## QUALIFICATIONS:

- A Bachelor’s, Master’s, or PhD in a scientific, medical, or regulatory discipline and 12+ years of progressively responsible experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, including significant Regulatory CMC experience supporting late-stage development and/or commercial products.
- Experience in managing commercial programs marketed in US, EU, Canada and other major markets
- 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.

## About Xenon Pharmaceuticals

## Company Overview
- **One-liner**: Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing therapeutics for people living with neurological and psychiatric disorders.
- **Entity Type**: Public (Ticker: XENE on Nasdaq)
- **Headquarters**: Burnaby, British Columbia, Canada
- **Founded**: 1996
- **Founders**: Not publicly listed as individual founders; the company was founded based on a platform science capable of discovering new genetic targets to treat human disease.

## Core Business
- **Primary industry/industries**: Biotechnology, Neuroscience, Pharmaceuticals
- **Target customers**: Patients with neurological and psychiatric disorders (epilepsy, major depressive disorder, bipolar depression, pain); healthcare providers; payers.
- **Mission or purpose statement**: "To deliver innovative medicines that provide a brighter future for people living with neurological and psychiatric disorders." [xenon-pharma.com](https://xenon-pharma.com/about)

## Products & Services
Xenon’s pipeline is focused on ion channel science, specifically potassium (KV7) and sodium (NaV) channel modulators.

- **Azetukalner (KV7 Potassium Channel Opener)**: The lead late-stage investigational candidate. It is in multiple Phase 3 clinical trials for:
    - Focal onset seizures (Phase 3 X-TOLE2 completed, X-TOLE3 ongoing)
    - Primary generalized tonic-clonic seizures (Phase 3 X-ACKT)
    - Major depressive disorder (Phase 3 X-NOVA2 and X-NOVA3)
    - Bipolar depression (Phase 3 X-CEED)
- **XEN1120 (KV7 Potassium Channel Opener)**: An early-stage (Phase 1) candidate for the treatment of pain.
- **XEN1701 (NaV1.7 Sodium Channel Inhibitor)**: An early-stage (Phase 1) candidate for the treatment of pain.
- **NBI-921355 (Partnered with Neurocrine Biosciences)**: A NaV1.2/1.6 inhibitor in development for epilepsy, pain, and psychiatry. [xenon-pharma.com](https://xenon-pharma.com/pipeline)

## Market Standing
- **Valuation/Market Cap**: Not publicly available in the provided search results. As a public company, this fluctuates daily.
- **Key Metric**: Annual Revenue of $7.5M (as per LinkedIn). As a clinical-stage biotech, the primary focus is on pipeline progress and cash runway rather than revenue.
- **Notable Investors/Partners**: Neurocrine Biosciences (partner for NBI-921355). The company has also had strategic partnerships with multiple premier biopharmaceutical companies focused on pain, metabolic, and cardiovascular disease. [xenon-pharma.com](https://xenon-pharma.com/about)
- **Growth Signals**: The company is in a significant growth phase, having initiated multiple Phase 3 clinical trials for its lead candidate, azetukalner, across epilepsy, major depressive disorder, and bipolar depression. This represents a major expansion of its clinical pipeline and a transition towards a late-stage, fully integrated biopharmaceutical company. [xenon-pharma.com](https://xenon-pharma.com/about)

## Competitive Advantages
- **Deep Expertise in Ion Channel Biology**: Xenon is one of the scientific leaders in ion channel drug discovery, with a specific focus on potassium (KV7) and sodium (NaV) channel modulators. This is a highly specialized and technically difficult area of drug development. [xenon-pharma.com](https://xenon-pharma.com/about)
- **Proprietary Pipeline**: The company has a wholly-owned, late-stage pipeline led by azetukalner, a novel KV7 potassium channel opener being studied across multiple high-need indications (epilepsy, MDD, bipolar depression). This provides significant potential upside and control over its future.
- **Strong Scientific Foundation**: Founded on a platform capable of discovering new genetic targets, the company has a deep history of translating genetic insights into novel therapeutic candidates. [xenon-pharma.com](https://xenon-pharma.com/about)
- **Strategic Partnerships**: A history of partnerships with premier biopharmaceutical companies (e.g., Neurocrine Biosciences) validates its platform and provides non-dilutive funding. [xenon-pharma.com](https://xenon-pharma.com/about)

## Strategic Focus
- **Advancing Late-Stage Pipeline**: The primary focus is on executing the Phase 3 clinical programs for azetukalner across epilepsy, major depressive disorder, and bipolar depression, with the goal of regulatory approval and commercialization.
- **Expanding Early-Stage Pipeline**: Continuing to advance early-stage candidates (XEN1120, XEN1701) for pain and other high-need indications.
- **Building a Fully Integrated Company**: Transitioning from a discovery and development company to one with commercial capabilities, as evidenced by the hiring of a Chief Commercial Officer. [xenon-pharma.com](https://xenon-pharma.com/about)
- **Deepening Ion Channel Leadership**: Maintaining its position as a scientific leader in ion channel drug discovery, with a deep focus on potassium (KV7) and sodium (NaV) channel modulators. [xenon-pharma.com](https://xenon-pharma.com/about)

## Why Work Here
- **Mission-Driven Work**: Employees are united by a clear and compelling mission to deliver innovative medicines for patients with neurological and psychiatric disorders who have been underserved for too long. [xenon-pharma.com](https://xenon-pharma.com/about)
- **Culture of Collaboration and Impact**: The company describes itself as collaborative, ambitious, resilient, ethical, and science-driven. The culture is shaped by the "XenonCARES" program, which focuses on professional growth, wellness, and community. [xenon-pharma.com](https://xenon-pharma.com/join-us)
- **Competitive Compensation & Benefits**: Offers a total compensation package including base salary, performance-based bonuses, and equity. Benefits include comprehensive medical, dental, and vision coverage (US and Canada), a retirement savings program with a generous employer match, and a tuition reimbursement program. [xenon-pharma.com](https://xenon-pharma.com/join-us)
- **Work Flexibility**: The company values flexibility and provides a stipend for work-from-home setups. They also offer generous paid vacation time and an annual holiday shutdown. [xenon-pharma.com](https://xenon-pharma.com/join-us)
- **Growth & Development**: Recognizes and supports team member growth through leadership and development opportunities, a tuition reimbursement program, and recognition programs for both big and small wins. [xenon-pharma.com](https://xenon-pharma.com/join-us)
- **Work Model**: Hybrid/Remote-friendly with a stipend for home office setups. Offices are located in Burnaby, British Columbia (HQ) and the United States. [xenon-pharma.com](https://xenon-pharma.com/join-us)
- **Diversity & Inclusion**: The company states it cultivates and celebrates diversity, viewing diverse backgrounds, experiences, and opinions as a great asset, and is committed to fostering a safe and inclusive environment. [xenon-pharma.com](https://xenon-pharma.com/join-us)

## Sources
1. [xenon-pharma.com](https://xenon-pharma.com/)
2. [xenon-pharma.com](https://xenon-pharma.com/about)
3. [xenon-pharma.com](https://xenon-pharma.com/join-us)
4. [xenon-pharma.com](https://xenon-pharma.com/pipeline)
5. [linkedin.com](https://www.linkedin.com/company/xenonpharma)

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