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Job Overview
Location
Remote
Job Type
Full-time
Category
Operations
Date Posted
February 12, 2026
Full Job Description
đź“‹ Description
- • Xenon Pharmaceuticals, a dynamic neuroscience-focused biopharmaceutical company, is seeking a visionary Vice President, Regulatory Affairs (Advertising, Promotion, and Labeling) to establish and lead two critical functions: Commercial Regulatory Affairs and Regulatory Labeling. This executive role is pivotal in shaping the company's compliance strategy as we advance our innovative product pipeline, including our Phase 3 azetukalner program for epilepsy and depression, and early-stage research in pain. You will be instrumental in ensuring our life-changing therapeutics meet all FDA and global health authority requirements for promotional materials and product labeling, fostering compliant business growth.
- • As the leader of Commercial Regulatory Affairs, you will build and champion a robust function encompassing policies, processes, and governance for promotional review. Your deep expertise in FDA regulations, guidance, and enforcement trends governing advertising and promotion of prescription drugs will be essential. You will provide strategic and operational leadership to cross-functional teams, including Marketing, Medical Affairs, Legal, and Clinical, guiding them in developing compliant promotional materials that align with our ambitious business objectives.
- • A key responsibility will be the detailed review of clinical evidence to support proposed claims, ensuring absolute consistency with FDA-approved labeling. You will oversee the comprehensive review and approval of promotional materials across all channels – digital, print, social media, training programs, and press releases – ensuring a unified and compliant message.
- • You will serve as the primary liaison with the FDA's Office of Prescription Drug Promotion (OPDP), expertly managing advisory comment requests, navigating negotiations, and overseeing the pre-clearance of crucial launch materials. Furthermore, you will ensure the timely submission of all approved promotional materials to the FDA on Form 2253, maintaining meticulous records and adherence to deadlines.
- • Proactive monitoring of regulatory developments and enforcement actions is critical. You will be responsible for keeping stakeholders informed of changes and proactively guiding risk mitigation strategies to safeguard the company.
- • In parallel, you will establish and lead the Regulatory Labeling function, defining its governance, processes, and systems for efficient labeling development and lifecycle management. This includes overseeing the creation and ongoing management of prescribing information, patient labeling, and packaging components for all Xenon products.
- • Ensuring labeling compliance with both FDA and global health authority requirements is paramount. You will manage updates driven by regulatory changes, emerging safety signals, or new clinical data, ensuring our product information remains accurate and compliant.
- • You will forge strong partnerships with Clinical, Medical, and Commercial teams to strategically align labeling development with overarching product development and commercialization plans. Implementing rigorous labeling change control processes and ensuring the timely submission of updated labeling to regulatory authorities will be a core function.
- • Developing and maintaining consistent labeling standards and templates across all global markets will be a key contribution, ensuring uniformity and clarity.
- • You will represent the labeling function effectively in cross-functional teams and during interactions with regulatory agencies.
- • Beyond these core functions, you will play a vital leadership role in organizational development. This includes recruiting, developing, and mentoring regulatory professionals to build high-performing teams for both Commercial Regulatory Affairs and Labeling. You will foster a culture of excellence, innovation, and accountability, recognizing and rewarding initiative and performance.
- • Establishing key performance indicators (KPIs) for regulatory review and labeling processes will enable you to lead continuous improvement initiatives, ensuring efficiency and effectiveness.
- • You will also be responsible for developing and proposing short- and long-term objectives for your functions, aligning them with Xenon's overall company strategies and plans. Budget management, including proposal and oversight of approved budgets, will be conducted in accordance with company policies.
- • Acting in accordance with all company policies, including the Code of Business Conduct and Ethics, and ensuring these are understood and followed by your direct reports, is a fundamental expectation.
- • This role offers the opportunity to shape regulatory strategy at a growing biopharmaceutical company, directly impacting the successful commercialization of novel neuroscience therapeutics and contributing to Xenon's mission of improving patient lives.
🎯 Requirements
- • Bachelor's degree in a scientific discipline; an advanced degree (MD, PharmD, PhD) is strongly preferred.
- • Minimum of 15 years of progressive regulatory leadership experience within small and large multinational biopharmaceutical companies.
- • Significant direct experience in advertising, promotion, and labeling review and strategy is required.
- • Comprehensive knowledge of FDA and global regulations pertaining to labeling and promotional compliance.
- • Demonstrated experience in building regulatory teams, systems, and processes that can scale with company growth.
🏖️ Benefits
- • Competitive total rewards package including base salary, target bonus, and stock options.
- • Comprehensive health benefits: medical, dental, and vision insurance.
- • Robust insurance coverage: short- and long-term disability, accidental death & dismemberment, and life insurance programs.
- • Additional employee support: Employee Assistance Program and travel insurance.
- • Retirement savings program with company matching contributions.
- • Generous time off: vacation, personal days, sick days, and an end-of-year company shutdown.
- • Investment in employee growth: expanding Training, Learning & Development program, including Tuition Assistance for advanced degrees.
Skills & Technologies
REST
Remote
Degree Required
About Xenon
Xenon is a leading provider of advanced data analytics and artificial intelligence solutions. The company specializes in developing and implementing cutting-edge technologies that help businesses unlock the full potential of their data. Xenon's offerings include predictive modeling, machine learning algorithms, and data visualization tools, all designed to drive informed decision-making and operational efficiency. They serve a diverse range of industries, including finance, healthcare, and retail, empowering clients to gain deeper insights, optimize performance, and achieve strategic business objectives. Xenon is committed to innovation and delivering tangible value through data-driven strategies.
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