Commercial Regulatory Affairs Director

SUMMARY/JOB PURPOSE:  

Responsible for primary regulatory review of promotional materials and scientific exchange communications. This role demonstrates proficiency in understanding and interpreting Federal regulations and guidance documents and company standard operating procedures (SOPs) to support the advertising and promotions of Exelixis’ FDA (Food and Drug Administration) approved products, as well as materials for scientific-exchange communications.  This role recognizes the different requirements and restrictions for external data communication and presentation and represents the Regulatory considerations and point of view. This role demonstrates cross-functional leadership, recognizing opportunities for multi-disciplinary collaboration and challenges regarding communication strategies and initiatives that cross multiple channels. 

ESSENTIAL DUTIES AND 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. Able to recognize issues requiring escalation and lead RAMP through escalation process. 

• 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). Decision-making member of the Medical and Scientific Exchange Review Committee. 

• Reviews and approves clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters. 

• Effectively collaborates with cross-functional internal groups including Marketing, Legal, Medical, Market Access, and other groups as needed. 

• 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. Oversee and manage training on processes and systems. 

• 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. 

SUPERVISORY RESPONSIBILITIES: 

• None 

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:  

Education/Experience: 

• 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 educatio