Commercial Regulatory Affairs Director

Commercial Regulatory Affairs Director

Requirements

• Bachelor’s degree in related discipline and a minimum of thirteen years of related experience; or,
• Master’s degree in related discipline and a minimum of eleven years of related experience; or,
• PhD degree in related discipline and a minimum of eight years of related experience; or,
• Equivalent combination of education and experience.
• Extensive knowledge of the regulatory framework, industry drivers and practices.
• Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.
• Demonstrates clear and effective verbal and written communication.

Responsibilities

• Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval, and implementation of promotional materials and other related activities with an increased level of independence.
• Provides timely and solutions-oriented reviews of assigned advertising and promotion materials with a high level of independence.
• Responsible for the regulatory review and approval of advertising and promotional materials and scientific exchange communications.
• Serves as decision-making member of the Review of Advertising, Marketing, and Promotions (RAMP) committee and/or Medical Review committee (MRC).
• Serves as RAMP Chair overseeing the review and approval of RAMP and/or MRC materials.
• Provides regulatory guidance for the development, review, implementation, and maintenance of promotional materials and other related activities with a high level of independence.
• Effectively collaborates with cross-functional internal groups including Marketing, Legal, Medical, Market Access, and other groups as needed.
• Manages the development of relevant correspondence with health authorities and interpretation of health authority comments.
• Responsible for the regulatory review and approval of scientific exchange materials, including Medical Information requests, materials for the Medical Affairs field staff, and clinical trial support materials (e.g., external patient recruitment materials).
• Reviews and approves clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters.
• Provides strategic and forward-looking guidance regarding processes and systems surrounding review committees.
• Provides leadership within the Commercial Regulatory Affairs department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.
• Responsible for oversight of promotional material submissions under Form FDA 2253.
• Maintains current awareness of evolving health authority interpretations, including advisory letters, enforcement letters, policy issues and guidance recommendations.
• Conducts benchmarking project for new initiatives and/or activities.
• Reviews and evaluates industry environment; performs competitive intelligence on promotional materials and activities.
• Manages, maintains, and continuously improves processes and systems (including a web-based platform) for review and approval of promotional materials.
• Leads creation and maintenance of Commercial Regulatory SOPs and work instructions for review, approval, and maintenance of promotional materials.
• Mentors and provides oversight to junior department members supporting Commercial Regulatory Affairs activities.

Preferred Qualifications

• Ability to manage effectively performing teams, facilitates team alignment and achievement of common objectives.
• Engages internal and external stakeholders to establish productive collaborative relationships.
• Understands longer term consequences of decisions and actions.