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ProfileSenior Counsel, Regulatory Law The candidate will be a member of the Global Regulatory Legal Team and provide specialized legal support to assigned therapeutic area(s) in the Pharmaceutical Sector of the company. Be responsible for advising clients on FDA regulatory matters and compliance with laws, regulations, industry standards and company policies that arise throughout the product lifecycle, including in the areas of product development, advertising and promotion, research, and quality. Provide legal counsel on health care laws, including the Federal Anti-Kickback Statute, and related health care legal obligations and on legal requirements related to privacy and data protection. Provide advice on marketing and sales activities and programs, including review of advertising and promotional materials, and will work with clients to develop appropriate and compliant strategies for interacting with healthcare providers, payors, and other stakeholders. Advise clients on life cycle management strategies. Effectively provide and coordinate legal support in these fields, be a member of the relevant functional teams supporting assigned therapeutic area(s) and interact with business and Law Department management on these matters. Engage in initiatives with trade associations and policy teams related to regulatory issues. Work closely with other Law Department colleagues to provide consistent and efficient legal support to the company. A Juris Doctor Degree with admission to (and current good standing with) the bar of at least one state or the District of Columbia is required. 5+ years of experience advising clients on FDA regulatory matters is required, a focus on pharmaceutical and biotechnology products is preferred. Experience: in the legal review of labeling materials and counseling on other aspects of regulatory strategy for product submissions and product lifecycle; advising on health care compliance obligations, including the U.S. Health Care Fraud and Abuse Laws, is strongly preferred; in a law firm supporting clients in the life sciences industry on regulatory matters or in a regulatory agency, such as the U.S. F.D.A., is strongly preferred. Must have excellent strategic and analytical skills, strong communication and presentation skills, and the ability to work independently and to collaborate on teams.
Requisition ID: 4306171108