Director, Regulatory Affairs, Commercial (Advertising & Promotion)

Xenon Pharmaceuticals•Needham, MA

1d•Hybrid

About The Position

Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics. We are seeking a Director, Regulatory Affairs, Commercial (Advertising & Promotion), to join our Regulatory Affairs team. The Director will be responsible for strategic regulatory advice and direction for marketed products and development compounds in alignment with the overarching regulatory and brand strategy. The Director will have oversight of day-to-day activities for their assigned role, department activities, and direct reports (if applicable) in order to meet goals and objectives. This position reports to the Vice President, Regulatory Affairs, Commercial and will be based out of Boston, MA, USA in our Needham office. This is a Hybrid position requiring a minimum of two onsite days per week.

Requirements

At minimum, a relevant four-year undergraduate degree
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

Nice To Haves

An advanced degree is preferred

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
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