Xenon
Overview
Posted Friday, January 16, 2026 at 8:00 AM
Who We Are:
Xenon Pharmaceuticals ( NASDAQ: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 to address indications with high unmet medical need, including epilepsy and depression. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b X-TOLE study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In November 2025, we announced the completion of patient enrollment in our Phase 3 X-TOLE2 study, and topline data are anticipated in early 2026. We also have multiple Phase 3 azetukalner clinical trials in major depressive disorder (MDD) and bipolar depression (BPD) underway, based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. We have recently initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, in 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 Senior Director, Regulatory Affairs, CMC and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. For Boston based candidates, this is a hybrid position, requiring a minimum of 2 days per week in the office.
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.
Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, timely resolution of issues, and the approval of regulatory applications.
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.
Develop, review, and maintain Regulatory CMC department policies and SOPs.
Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines, and other international regulatory regulations and guidelines, as needed to support global clinical and commercial programs.
Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
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.
Other duties as assigned.
Qualifications
A Bachelor’s, Master’s, or PhD in a scientific, medical, or regulatory discipline and 10+ years of management experience or combination of degrees and experience of progressively responsible Regulatory Affairs in a pharmaceutical, biotechnology, or related environment required.
Experience in managing commercial programs marketed in US, EU, Canada and other major markets.
Experience in rare disease indications and/or orphan drug development is desirable.
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.
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.
The base salary range for this role is
$215,656 - $233,100 USD ; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
Benefits and Total Rewards 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.
As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.
US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.
#J-18808-Ljbffr
Who We Are:
Xenon Pharmaceuticals ( NASDAQ: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 to address indications with high unmet medical need, including epilepsy and depression. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b X-TOLE study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In November 2025, we announced the completion of patient enrollment in our Phase 3 X-TOLE2 study, and topline data are anticipated in early 2026. We also have multiple Phase 3 azetukalner clinical trials in major depressive disorder (MDD) and bipolar depression (BPD) underway, based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. We have recently initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, in 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 Senior Director, Regulatory Affairs, CMC and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. For Boston based candidates, this is a hybrid position, requiring a minimum of 2 days per week in the office.
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.
Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, timely resolution of issues, and the approval of regulatory applications.
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.
Develop, review, and maintain Regulatory CMC department policies and SOPs.
Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines, and other international regulatory regulations and guidelines, as needed to support global clinical and commercial programs.
Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
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.
Other duties as assigned.
Qualifications
A Bachelor’s, Master’s, or PhD in a scientific, medical, or regulatory discipline and 10+ years of management experience or combination of degrees and experience of progressively responsible Regulatory Affairs in a pharmaceutical, biotechnology, or related environment required.
Experience in managing commercial programs marketed in US, EU, Canada and other major markets.
Experience in rare disease indications and/or orphan drug development is desirable.
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.
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.
The base salary range for this role is
$215,656 - $233,100 USD ; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
Benefits and Total Rewards 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.
As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.
US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.
#J-18808-Ljbffr