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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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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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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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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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7 or More Years relevant pharmaceutical experience including experience within Regulatory Affairs. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
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Health Authority Submission Preparation: Assist with preparation of pre-submission documents and CDx related portions of therapeutic marketing applications and respond to regulatory queries/feedback from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissions.
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Assist with preparation of pre-submission documents and CDx related portions of therapeutic marketing applications and respond to regulatory queries/feedback from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissions.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We’re immediately hiring a US Regulatory Affairs Lead for Personal Care and Sleep who is proficient in cosmetics, dietary supplements, and OTC products. US Regulatory Affairs Lead, Personal Care Brands page is loaded.
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Minimum 5 years in Regulatory Affairs, including leadership roles. Ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across the following regulatory classes (OTC monograph drugs, dietary supplements, cosmetics, foods and medical devices.
$95.7 - $110.7 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Join Our Team as a Remote Regulatory Affairs Specialist II! Qualifications: Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on IND maintenance activities for oncology products.
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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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Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area. 3-5 years as a Regulatory Affairs professional working on medical device projects.
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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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Bachelor or Master’s Degree in a scientific area (Degree in Pharmacy/Regulatory Affairs is preferred) 2-3 years’ experience in the pharmaceutical industry with 1-2 of those years in regulatory affairs preferred.
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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.
ExpandApply NowActive JobUpdated 14 days ago
Title: regulatory affairs in Bridgewater, NJ
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