Director, Regulatory Affairs, CMC

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 flagship 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 August 2025, we announced the completement of patient recruitment 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, and 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 Vancouver, BC, Canada. 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 Vancouver based candidates, this is a hybrid position, requiring a minimum of 2 days per week in the office.

RESPONSIBILITIES:

- Proposeand implement globalCMCregulatory strategies andprovideregulatory guidance to cross-functional teams and functional areasfor assignedprogramsfrom 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 activitiesare in compliance withapplicable regulations and guidelines.

- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.

- Plan, manage, author, review,and obtain stakeholder alignment tofacilitatethe submission of high-quality CMC sections of regulatory submissions to support initial INDs/CTAs, marketing applications,supplementsand variations.

- Work closely with Technical Writers to ensure CMC sections of regulatory submissions areaccurateand compliant.

- Lead multidisciplinary teamspreparing responses to Regulatory Agency questions.

- Effectively plan,organizeand contribute to formal meetings with global regulatory agencies to ensure alignmentonCMC strategies, resolve CMC issues and oversee proactive interactions forinitialINDs/CTAs, marketing registration applications,supplementsand variations.

- Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, thetimelyresolution of issues, and the approval of regulatory applications.

- Provide regulatory support for relevant quality systems such as change control,deviationt, and inspection management.Assess proposed manufacturing process changes andprovidestrategic regulatory guidance to enable global implementation.

- Develop, review, andmaintainRegulatoryCMCdepartmental policies and SOPs.

- Maintain up to date knowledge andexpertisewith 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 withthe Company’s Human Resource policies and practices.

- Develop and propose short- and long-termobjectivesfor the functionin accordance withoverall Company strategies and plans

- Actin accordance withCompany 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 and10+yearsof management experienceor combination of degrees and experience ofprogressively responsible Regulatory Affairs in a pharmaceutical, biotechnology, or related environmentrequired.

- Experience in managing commercial programs marketed in US, EU,Canadaand other major markets

- Experience in rare disease indications and/or orphan drug developmentisdesirable.

- Demonstrated, hands-on experience, managing and preparing regulatory submissions includingINDs/CTAs and/or marketing applications, supplements and variations in US and other major markets.

- Demonstratedtrack recordof successfulglobalregulatory submissions and strategies.

- Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.

- Detailoriented 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.

- Proficiencywith Microsoft Excel, PowerPoint, Project, and Word programs.

- Experience with Veeva RIM is desirable.

The base salary range for this role is $170,350 – $201,300 CAD; we will consider abovethis 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.

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.

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