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Years of Experience
ProfileAssociate Counsel, Regulatory Affairs The candidate coordinates with various departments, including Quality Assurance and sales and promotion, on defining and investigating optimal solutions. Advise, counsel, and actively participate in the development of procedures, practices, and systems that ensure compliance with regulatory standards, with particular emphasis on the FDA’s quality system, PDMA, and pharmaceutical reporting standards. Provide counsel and advice to the company on regulatory and legal- related matters ,with particular emphasis on FDA and regulatory issues. Coordinates the development, revision, review and approval of primary and secondary labeling. Contributes to the continuous improvement of the end to end labeling process. Assists in managing and responding to regulatory agency investigations and administrative actions, with particular emphasis on FDA, DEA, HHS and other issues. Provides regulatory reviews and analyses of existing products and new product launches. Monitors and tracks proposed healthcare-related regulations that will impact the company’s business. Develops and presents plans to senior-level leadership that result in modifications to existing or proposed regulations that allow for Acella to offer complete array of product portfolio.
Qualification and Experience
The candidate should have Law degree from an accredited law school, preferably with a focus in Health Policy or Regulatory Affairs are needed. Licensed to practice law in the state of Georgia is needed. Should have 5+ years of experience, with experience related to Title 21 of the Code of Federal Regulations and other law applicable to the pharmaceutical industry, and also advertisement and promotional review (related industry experience will be considered). Strong knowledge of FDA requirements, and applicable submission and reporting processes is needed. Excellent verbal and written communication, negotiation and collaboration skills is essential. In-house experience in a pharmaceutical company preferred, although relevant experience in law firm or government will be considered.
Acella Pharmaceuticals, LLC
11675 Great Oaks Way,
Alpharetta, GA 30022