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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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This position reports to VP, CDMA with a dotted line reporting relationship to the CSO. The Senior Director CDMA will interact with internal colleagues in Research and Development (Clinical Development & Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management,Commercial and Operations functions.
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7 or More Years relevant pharmaceutical experience including experience within Regulatory Affairs. D., Ph. D., MD, JD) preferred. Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.
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Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
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For base business hybrid responsibility, key constellation includes local brands teams (including science hub), respective category brand team, respective category claims lead and regional scientific affairs and activation teams.
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Represents medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions.
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He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
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The Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.
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This position reports to the VP, Global Regulatory Affairs. Regulatory Affairs - Bridgewater, NJ - Full Time Summary. Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs. The Associate Director, Regulatory Affairs will be accountable for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development.
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Establish and maintain effective team partnerships within HEVA and with key partners such as Value and Access and Medical Affairs+ Establish a strategy for publications support from the HUB and with expert vendor support and ensure performance and quality.
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Leading Pharmaceutical Company located in NJ is hiring a Manager, Global Medical Affairs Strategy and Execution w/ 5+ years industry experience. Title: Manager, Global Medical Affairs Strategy and Execution (Publications.
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Ethicon Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Regulatory Affairs Program Lead to support our Wound Closure and Healing portfolio. The Senior Regulatory Affairs Program Lead has end to end responsibility for the life cycle maintenance and new product development launches within the Wound Closure and Healing portfolio.
$105,000 - $160,000 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization and Operations.
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Title: affairs Company: Sanofi in Bridgewater, NJ
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