Director, Regulatory Affairs, Commercial… at Xenon… · Needham

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 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.

About the Role:

We are seeking a Director, Regulatory affairs, Commercial (Advertising & Promotion), to join our Regulatory Affairs team. The Director will be responsible for strategic regulatory advice and direction for marketed products and development compounds in alignment with the overarching regulatory and brand strategy. The Director will have oversight of day-to-day activities for their assigned role, department activities, and direct reports (if applicable) in order to meet goals and objectives. The Director will report to the VP of Commercial Regulatory Affairs.

This position reports to the Vice President, Regulatory Affairs, Commercial and will be based out of Boston, MA, USA in our Needham office. This is a Hybrid position requiring a minimum of two onsite days per week.

RESPONSIBILITIES:

• Provide strategic regulatory advice, review, and decisions for product promotion, disease state education, pipeline, and Medical materials for alignment with applicable FDA regulations and guidance documents
• Provide strategic regulatory support to the business by generating innovative solutions and effective problem-solving aligned with the company’s guiding principles in order to achieve desired outcomes
• Develop and establish strong internal cross-functional relationships with the Commercial, Medical Affairs, Legal, Compliance, Corporate Affairs, and Development to foster open communication, collaboration, and teamwork
• Continually monitors and evaluates the regulatory environment, interprets new regulations, guidance documents, enforcement activities and trends for potential impact on the business and company
• Maintain in-depth understanding of clinical trial design and interpretation of clinical data and communicate complex issues clearly and concisely
• Establishes and maintains a relationship with the Office of Prescription Drug Promotion (OPDP) at FDA
• Provide appropriate oversight of promotional material review and ensure on-time and accurate submission of applicable materials to FDA
• Assist with training employees at Xenon and in developing and improving process efficiencies
• 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:

• At minimum, a relevant four-year undergraduate degree; An advanced degree is preferred
• 10+ years of experience in progressive Regulatory Affairs management positions in the biotech or pharmaceutical industry; A minimum of 8 years of experience focused on Regulatory Advertising and Promotion
• Strong verbal and written communication skills; interpersonal and listening skills implemented in a positive and effective manner
• Expertise in applicable FDA laws, regulations, guidances, and industry standards
• Ability to manage a complex matrixed environment with multiple competing priorities and tasks appropriately and with autonomy
• Strong communication, leadership and interpersonal skills required

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.