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Sanofi Consumer Healthcare US (formerly Chattem) is a leading marketer and manufacturer of a broad portfolio of branded over-the-counter (OTC) healthcare products, in such categories as allergy, upper and lower gastrointestinal, skin care, topical pain care, oral care and other OTC toiletry products.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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Sanofi Group US Regulatory Operations Lead, CHC Bridgewater , New Jersey Apply Now US Regulatory Compliance & Operations Lead, CHC. Ensure regulatory expertise into simplification of our processes & workflows in areas such as MLR approval process within NA & Veeva Vault documentation working with global team as needed.
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BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience, or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required.
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Join Sanofi General Medicines Global Regulatory Team as Global Regulatory Team Leader (GRTL). Additionally, you will be responsible for acting as the global regulatory lead responsible for new development opportunities and executing the maintenance activities for their assigned products for oncology and transplant in General Medicines and Global Health portfolio.
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Interact with a cross-functional team in the collection including Global Health program and business, review and assembling of the scientific, clinical, manufacturing and administrative section documents for global submissions to regulatory authorities.
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Global Regulatory Team Leader Oncology and Transplant. 5+ years of experience in Regulatory Affairs or relevant industry experience. Lead a portfolio of mainly Core asset marketed products for assigned Therapeutic Area (TA) in mainly in US, Europe and key worldwide markets by actively contributing to the development and implementation of innovative regulatory strategies and timelines.
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The Regulatory Affairs Director’s role is to lead regulatory strategy, regulatory filings and health authority interactions to support the clinical development for clinical stage oncology products at Amunix, a Sanofi company.
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Develop regulatory strategy to enable clinical trials and to maintain the ongoing clinical trials in EU, US and Asia regions. Provide regulatory affairs guidance and support for the ongoing clinical studies.
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