Director, Regulatory Affairs, Commercial (Advertising & Promotion)

Xenon

Job Overview

Location

Boston

Job Type

Full-time

Full Job Description

📋 Description

• Provide strategic regulatory advice and decision-making for promotional materials, disease state education, and medical communications aligned with FDA regulations and guidance documents for marketed products and development compounds.
• Oversee day-to-day regulatory activities related to advertising and promotion, ensuring compliance with applicable laws and company policies across all commercial materials.
• Serve as the primary regulatory liaison with the FDA’s Office of Prescription Drug Promotion (OPDP), maintaining proactive communication and ensuring timely submission of promotional materials.
• Review, approve, and ensure accuracy of all promotional and educational materials prior to dissemination, including digital, print, and speaker programs.
• Monitor evolving regulatory landscape, interpret new FDA guidance, enforcement actions, and industry trends to assess impact on commercial strategies and mitigate compliance risks.
• Collaborate cross-functionally with Commercial, Medical Affairs, Legal, Compliance, Corporate Affairs, and Clinical Development teams to align promotional strategies with regulatory requirements and business objectives.
• Develop and implement process improvements to enhance efficiency and consistency in promotional material review and submission workflows.
• Lead training initiatives for internal teams on regulatory expectations, FDA guidelines, and compliance best practices related to advertising and promotion.
• Maintain in-depth understanding of clinical trial design, data interpretation, and therapeutic areas including epilepsy, depression, and pain to provide contextually accurate regulatory guidance.
• Ensure all regulatory activities adhere to Xenon’s Code of Business Conduct and Ethics, and foster a culture of compliance among direct reports and cross-functional partners.
• Support regulatory submissions for new indications by providing input on promotional strategy alignment with clinical data and labeling.
• Contribute to the development of regulatory strategy for pipeline assets, particularly azetukalner in focal onset seizures, major depressive disorder, and bipolar depression, ensuring promotional readiness.
• Manage relationships with internal stakeholders to ensure timely, accurate, and compliant communication of product information across all channels.
• Act as a subject matter expert on FDA regulations governing prescription drug promotion, including 21 CFR Part 202, 21 CFR Part 200, and relevant guidances.
• Participate in the preparation of regulatory submissions and responses to FDA inquiries related to promotional activities.
• Support the VP of Commercial Regulatory Affairs in setting departmental goals, managing performance of direct reports, and driving team development.
• Ensure all promotional materials are submitted to FDA in accordance with required timelines and formats, including pre-dissemination review and post-dissemination reporting.
• Maintain up-to-date knowledge of industry standards and best practices in pharmaceutical advertising and promotion, including adherence to PhRMA Code and OIG guidance.
• Contribute to the continuous improvement of regulatory policies, procedures, and training programs to reflect current regulatory expectations and company growth.
• Represent Regulatory Affairs in internal audits, inspections, and regulatory agency interactions related to promotional activities.
• Balance multiple competing priorities in a fast-paced, matrixed environment while maintaining high standards of accuracy and compliance.
• Support the commercialization strategy for azetukalner as it approaches potential FDA submission in Q3 2026, ensuring promotional materials are fully compliant and ready for launch.

🎯 Requirements

• 10+ years of progressive Regulatory Affairs management experience in biotech or pharmaceutical industry
• Minimum of 8 years focused specifically on Regulatory Advertising and Promotion
• Expertise in FDA laws, regulations, guidances, and industry standards for prescription drug promotion
• Bachelor’s degree in a relevant field; advanced degree preferred
• Strong verbal and written communication skills with proven ability to influence cross-functional teams
• Experience managing complex matrixed environments with multiple competing priorities

🏖️ Benefits

• Base salary, target bonus, and stock options
• Comprehensive medical, dental, and vision insurance
• Retirement savings programs with company matching contributions
• Vacation, personal days, sick days, and end-of-year company shutdown
• Tuition Assistance program for advanced degrees
• Employee Assistance Program and travel insurance

Skills & Technologies

REST

Hybrid

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Xenon

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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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