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Senior Director Head of Regulatory Law
Experience
12 yrs required
Location
Princeton, NJ, United States
Posted on
Nov 28, 2022
Profile
Senior Director, Head of Regulatory Law
Responsibilities: Serve as primary U.S. regulatory lawyer at Sun and Taro and as a Legal advisor on FDA and CMS regulatory compliance matters, including quality related issues (e.g., market actions/recalls, stop sales, quality issues/communications), FDA strategy, and on pricing, patient access, and government price reporting. Act as Business partner to R&D, regulatory affairs, and business development teams on product development and drug approval pathways, and on R&D and commercial issues. Review marketing and promotional initiatives, programs presenting healthcare fraud and abuse risks, and product launch strategies. Advise government teams on price transparency reporting requirements. Develop, review, and approve company policies and SOPs. Review and assess state legislative initiatives, develop and recommend corporate positions, represent companies with trade association legislative/lobbying and policy committees. Serve as a senior lawyer on a collaborative and dedicated legal team.
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