Director, Regulatory Affairs, Commercial (Advertising & Promotion)

About the role

We are seeking a Director, Regulatory Affairs, Commercial (Advertising & Promotion) to join our Regulatory Affairs team. The Director will provide strategic regulatory advice, support, and oversight for marketed products and development compounds in alignment with the company's regulatory and brand strategy. Responsibilities include strategic regulatory advice, support, and oversight for product promotion, disease state education, pipeline, and Medical materials. The Director will also develop and maintain relationships with key stakeholders and continuously monitor and evaluate the regulatory environment.

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
• 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
• Aid in 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

Qualifications

• 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