Regulatory Affairs Director
Responsible for provision of regulatory guidance to the organization for medical education and commercial advertising and promotion materials and acting as the lead regulatory reviewer for product, disease state and all medical education materials. The individual will chair the Commercial Copy Approval Committee and be responsible for timely and accurate review of all materials prepared by the commercial organization for communication to HCP’s, consumers and field-based sales teams. In addition the incumbent will be the regulatory representative on the Medical Review Committee and is responsible for conducting the regulatory review of materials used by the field medical team when communicating with HCP’s, formulary committees and payors. The individual will be familiar with FDAMA 114 and will be able to evaluate FDA guidances, policies and the overall regulatory environment and be able to assess and communicate potential impact to company management. Individual will be required to effectively interact with multiple functions across the organization, including executive management.
Bachelor’s degree or equivalent in a life science plus 7 years minimum experience in the pharmaceutical/biotech industry, preferably in regulatory affairs in an organization with commercial products. Individual must have prior experience and be the subject matter expert for the regulatory review of medical and promotional materials, both pre-approval and for product launch. A comprehensive knowledge of the regulations governing the promotion of medicinal products to HCP’s and provision of medical education materials and the requirements of FDAMA 114 is required. The position requires a detailed knowledge of the policies of the FDA’s OPDP. Position requires a strong attention to detail and excellent verbal and written communication skills.