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Carrot Peelers, Sales, Personality and Your Job Search
Recruiter
Attorney
Government / Public Law
Litigation - Whistleblower - CFTC
Min 10 yrs required
General Counsel Consulting (GCC) is the only professional firm that works full time to find openings and make placements for General Counsel and in-house counsel. By working only for in-house counsel over the years, we have developed exclusive resources for advancing your legal career. Principal Regulatory Affairs Labeling, Promotion and Advertising Duties: Ensures compliance to internal labeling, promotion and advertising policies and procedures as well as regulations and guidance set forth by regulatory authorities. Accountable for the development and delivery of training to applicable internal functions regarding current labeling, promotion and advertising regulations, FDA guidance, processes, and supporting tools. Be involved with responding to internal and external audits regarding labeling, advertising and promotional labeling. Support the management and implementation of the processes associated with the creation of new product labeling, and revisions to existing labeling content documents throughout the lifecycle of assigned products. Ensure the representation of labeling content is accurate on artwork, and that draft labeling is compliant with labeling regulations and FDA guidance. Participate in the development of labeling strategy, including ensuring that labeling content is sufficiently supported by submission documents, and remains current with labeling regulations and guidance as they pertain to assigned products. Be accountable for assigned promotional regulatory activities, including participation during relevant product development and launch activities. Accountable for the regulatory affairs review and approval of assigned drug product advertising and promotional labeling as well as sales training materials to help ensure that the information contained in these materials are not false or misleading. Contributes to providing clear and unambiguous communication of the laws, regulations and regulatory agency guidance relating to product promotion to internal sponsors of communication activities or functions (e.g., Marketing, Medical Affairs (scientific publications), Public Relations (external presentations and press releases), and Sales Training (materials and tools). Qualifications: Bachelors degree, typically from the pharmaceutical/health/science/nursing disciplines. Masters (MS) or Professional degree (J.D., PharmD, MD) preferred. RAC preferred. 10 + years experience in the pharmaceutical industry (MS/ PharmD 4-7 years), with 7+ years experience in regulatory affairs required. 5 + years of regulatory affairs Advertising/Promotion and Labeling experience in the food, pharmaceutical, or medical device industries.
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