Director, Regulatory Affairs – Commercial, Advertising & Promotion

Xenon Pharmaceuticals Inc.

Director of Regulatory Affairs, Commercial (Advertising & Promotion) at Xenon Pharmaceuticals. Leading strategic regulatory advice for marketed products and development compounds in Boston.

Posted 5/21/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesLead💰 $224,600 - $248,400 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

Our Total Rewards program includes base salary, target bonus, and stock options
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
Encouragement of time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown
Expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees

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Hard Skills & Tools

regulatory affairsclinical trial designpromotional material reviewFDA regulationsregulatory advertisingregulatory complianceproblem-solvingprocess efficienciesdata interpretationstrategic regulatory advice

Soft Skills

communication skillsinterpersonal skillslistening skillsleadership skillscollaborationteamworkautonomypositive attitudeeffective problem-solvingrelationship building