Associate Director, Corporate Counsel - Regulatory & Commercial Counsel Jobs in New_York - 171515 | Submit Resume | General Counsel Consulting
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Associate Director, Corporate Counsel - Regulatory & Commercial
Refer job# LMEF171515
Associate Director, Corporate Counsel - Regulatory & Commercial The candidate will be providing day-to-day strategic legal counseling, as lead risk counselor, for one or more of Regeneron's products/product candidates from development through commercialization and lifecycle planning, including advising on a broad range of healthcare regulatory matters, including advertising and promotion, privacy, drug safety, market research, scientific exchange, interactions with healthcare professionals, market access, patient support programs, and external funding requests. Will provide business-focused legal guidance and counsel to commercial, medical, clinical, regulatory, compliance, market access and policy with a focus on healthcare laws, regulations, and the overall healthcare environment. Demonstrating an understanding of the strategic and tactical objectives of the client teams supported, developing creative and innovative solutions to key initiatives, taking into account the current legal and regulatory landscape. Utilizing a deep knowledge of pipeline and approved products to advise on BLA-submission activities, labeling, safety and risk mitigation development and activities. Counseling on all aspects of product commercialization, including launch preparation, launch execution, advertising and promotion, product communications, and strategic brand planning. Work collaboratively to support Compliance in their mission of developing policies, training, procedures, monitoring, risk mitigation and their support of the seven elements of an effective compliance program. Acting as a cross-functional liaison with the Intellectual Property, Dispute Resolution, Transactions and other key Law Department groups. Reviewing and approving of needs assessments of proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements. Assisting with a broad range of healthcare regulatory matters including monitoring the enforcement environment, client training, and compliance policy development. Possess a solid understanding of the biotech/pharmaceutical industry, including product development, commercialization, and the legal and regulatory environment. Must have a JD with excellent law school credentials. Must be licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. Should have 5+ years of legal experience at a law firm and/or in-house, including biotech/pharmaceutical and/or healthcare experience.
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