Vice President, Regulatory Affairs (Advertising, Promotion, and Labeling)

Xenon Pharmaceuticals • Needham, MA

35d • Hybrid

About The Position

We are seeking a Vice President, Regulatory Affairs (Advertising, Promotion, and Labeling) to join our team. The Vice President, Regulatory Affairs will establish and lead two critical functions—Commercial Regulatory Affairs and Regulatory Labeling—for a growing biotech organization. This executive will develop strategy, build teams, and implement systems to ensure compliance with FDA and global health authority requirements for promotional materials and product labeling. The role provides strategic leadership across Marketing, Medical Affairs, Legal, Clinical, and Commercial teams, guiding risk-based decisions and enabling compliant business growth. Responsibilities include regulatory intelligence, digital and global promotional oversight, labeling governance, and direct engagement with regulatory agencies.
This position reports to the Senior Vice President, Regulatory Affairs and Medical Writing, and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week.

Requirements

• Bachelor’s degree in a scientific discipline; advanced degree (MD, PharmD, PhD) strongly preferred.
• Minimum of 15 years of Regulatory leadership roles of increasing responsibility with small and large multi-national biopharma companies. Significant direct experience in advertising, promotion, and labeling required.
• Comprehensive knowledge of FDA and global regulations for labeling and promotional compliance.
• Experience with global product launches and lifecycle management.
• Strong strategic and operational skills; ability to balance short-term needs with long-term vision.
• Strong interpersonal and leadership skills to work both independently and collaboratively as part of multidisciplinary teams in a fast-paced, distributed and highly matrixed environment.
• Demonstrated experience in building regulatory teams, systems and processes appropriate to scale.
• High organizational awareness and ability to connect cross-functional priorities.

Responsibilities

• Build and lead the Commercial Regulatory Affairs function, including policies, processes, and governance for promotional review.
• Serve as internal expert on FDA regulations, guidance, and enforcement trends governing advertising and promotion of prescription drugs.
• Provide strategic and operational leadership to Marketing, Medical Affairs, Legal, and Clinical teams in developing compliant promotional materials aligned with business objectives.
• Conduct detailed review of clinical evidence supporting proposed claims; ensure consistency with FDA-approved labeling.
• Oversee review and approval of promotional materials across all channels (digital, print, social media, training, press releases).
• Serve as primary contact for FDA’s OPDP, managing advisory comment requests, negotiations, and pre-clearance of launch materials.
• Direct timely submission of all approved promotional materials to FDA on Form 2253.
• Monitor regulatory developments and enforcement actions; proactively update stakeholders and guide risk mitigation strategies.
• Establish and lead the Regulatory Labeling function, including governance, processes, and systems for labeling development and maintenance.
• Oversee creation and lifecycle management of prescribing information, patient labeling, and packaging components for all products.
• Ensure labeling compliance with FDA and global health authority requirements; manage updates driven by regulatory changes, safety signals, or new data.
• Partner with Clinical, Medical, and Commercial teams to align labeling strategy with product development and commercialization plans.
• Implement labeling change control processes and ensure timely submission of updated labeling to regulatory authorities.
• Develop labeling standards and templates; ensure consistency across global markets.
• Represent labeling function in cross-functional teams and regulatory interactions.
• Recruit, develop, and mentor regulatory professionals; build high-performing teams for both functions.
• Drive a culture of excellence, innovation, and accountability; reward initiative and performance.
• Establish KPIs for regulatory review and labeling processes; lead continuous improvement initiatives.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans
• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies
• Recruit, lead, 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 international travel may be required
• Other duties as assigned

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive