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Associate Regulatory Counsel-Legal
New York, NY
Our CompanyForest Laboratories, Inc. (FLI) is an innovative, growth-oriented prescription pharmaceutical company focused on developing top-quality therapies that help people lead healthier, more fulfilling lives. We take pride in meeting our business objectives and expanding our product franchises, but we also derive satisfaction in helping to bring relief to people who are suffering. Our products treat conditions such as depression, anxiety, Alzheimer's disease, hypertension and fibromyalgia, and we keep a focused eye on the future with a robust pipeline of compounds at virtually every stage of development. With headquarters in New York City and operations in New Jersey, Long Island, Missouri, Ohio, California, Ireland and the U.K, each of Forest's more than 5,000 employees contributes to our quest to deliver quality products with entrepreneurial spirit, unflagging integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest.Job detailsThe Assistant Regulatory Counsel is primarily responsible for supporting the Regulatory Counsel in advising the business on legal issues related to the company's development of its product portfolio. This position will advise R&D clients on a broad array of issues relating to pharmaceutical regulations, product development and product labeling. Additional areas of responsibility may include assisting the Regulatory Counsel in advising sales & marketing clients on FDA labeling and promotional matters, healthcare laws, and other areas related to the commercialization of pharmaceutical products.Main areas of responsibility: Provide legal advice and counsel with regard to:Clinical trial management and GCP complianceGlobal manufacturing and GMP compliance;Patient recruitment activities and informed consent processes;The development of product labelsThe development, management and reporting of product safety details, including the development of company core safety info from a global perspective. Assist with the legal review of advertising, promotional, sales training and press materials related to Forest's product portfolio and provide counsel to participants in the review process. Support the Regulatory Counsel as directed on special projects.Job responsibilitiesMin Requirements to be considered for this position:BA/BS and J.D are required5+ years background as a practicing attorney, with at least three years' background with legal,regulatory and compliance requirments in the pharamaceutical/bioindustry with emphasis on R&DLicensed to practice law in the United States or be eligible for licensure as a registered in-house counsel.Ideally applicants will also have:-Knowledgeable of the laws and regulations affecting the pharmaceutical industry, including the Food Drug and Cosmetic Act, Anti-Kickback Statute, and False Claims Act.-Good communication abilities, including presentation capabilities, people skills and conflict resolution.-Excellent negotiation skills requiring effective interpersonal communication and oral and written correspondence skills.-Expertise to independently manage workload in a fast-paced environment. Expertise to provide legal counsel to a wide variety of internal clients on legal and regulatory matters and interact effectively with employees at all levels of the organization.
October 30 on JobThread