Senior Director, Regulatory Affairs, CMC

Xenon Pharmaceuticals Inc.; Needham (MA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Xenon Pharmaceuticals Inc. is seeking a senior regulatory affairs CMC leader to supervise regulatory activities for major development and commercial assets.

This role requires driving global CMC submissions, coordinating with cross-functional teams across regulatory, quality, and supply to ensure readiness for marketing applications and variations. The ideal candidate will have 12+ years in Regulatory Affairs with track records across US, EU, and Canada, and strong communication skills.

Qualifications

• Bachelor’s/Master’s/PhD in scientific, medical, or regulatory field with 12+ years in Regulatory Affairs, incl. late-stage development and/or commercial products.
• Experience managing commercial programs in US, EU, Canada, and other major markets.
• Hands-on submissions experience: INDs/CTAs and/or marketing applications, supplements, variations.
• Track record of successful global regulatory submissions and strategies.
• Prior liaison with Regulatory Agencies is desirable.

Responsibilities

• Provide strategic regulatory CMC leadership for major development or commercial assets and advise cross-functional teams.
• Communicate regulatory risks and mitigations promptly to teams and stakeholders.
• Manage reporting requirements, including annual and periodic reports.
• Lead preparation and alignment of CMC sections for regulatory submissions (marketing applications, supplements, variations).
• Collaborate with CMC, Operations, Quality, Supply Chain, and Program Management to ensure regulatory readiness; work with Technical Writers for accurate CMC submissions.
• Lead multidisciplinary teams preparing responses to Regulatory Agency questions.
• Plan and conduct meetings with global regulatory agencies to align CMC strategies and resolve issues for late-stage or commercial programs.
• Support quality systems (change control, deviation, inspection management) and assess manufacturing changes for regulatory impact.
• Contribute to departmental objectives and continuous improvement in Regulatory Affairs CMC.
• Interpret emerging global regulatory requirements and advise on impact to development and commercial programs.
• Aid in recruitment, coaching, and evaluation of direct reports as applicable.
• Ensure adherence to Company policies and code of conduct; travel as required.
• Other duties as assigned.

Skills

Regulatory CMC leadership

Global regulatory submissions

Stakeholder management

MS Office suite (Excel, PowerPoint, PM

Veeva RIM (desirable)

Education

Bachelor/Master/PhD in science/regulatory

Tools

Veeva RIM

Microsoft Office

Job description

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, 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.