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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.
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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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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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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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Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations that may impact business.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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7 or More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs. Experience in providing regulatory strategic input into the Oncology drug development preferred.
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Prepare payments and manage the liabilities and expenses related to the tax returns; work with AP, Treasury, and various in-house payment systems Ensuring adherence to all SOX controls Assist with all Regulatory related audits, as needed Conduct research as needed, including the tax impact to all Regulatory filings with the addition of any new products and services The ability to prioritize deliverables with competing timelines is required.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Prior experience with performance improvement initiatives, and regulatory oversight, Knowledgeable about state, federal, and regulatory agency requirements, Director for Quality, Safety and Regulatory.
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Title: Manager, Global Medical Affairs Strategy and Execution (Publications)Location: Must be local Raritan, NJ and required to go onsite 2-3 days a weekType: EmbeddedStart Date: ASAPLeading Pharmaceutical Company located in NJ is hiring a Manager, Global Medical Affairs Strategy and Execution w/ 5+ years industry experience.
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Education equivalent to a PhD or MD degree or equivalent in a scientific field or experience in lieu of, plus at least 4 years experience in Regulatory Affairs; or. Education equivalent to a BS degree or equivalent in a scientific field or experience in lieu of, plus at least 8 years experience in Regulatory Affairs.
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The Executive Director of Advertising & Promotion- Regulatory Affairs prescription drug products manages and, if required participates in, the reviews and approvals of advertising and promotional labeling pieces for prescription drugs.
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Sr. Accounting / Financial Analyst (Regulatory Filings) Work with, understand and prepare Regulatory filings which include those filed with the Federal and State Regulatory Agencies and third-party fund administrators for all Client owned companies.
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Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases.
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Author product statements and documentation in compliance with international and country specific legislation (e.g. product dossiers, registration certificates) with the support of the SDS authoring specialist for label data, GHS classifications, Dangerous Goods classifications, worker safety or environmental risk assessments and with the support of the Regulatory affairs team for site specifics and environmental regulation.
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Ethicon, Inc., part of the Johnson & Johnson MedTech family of companies, is currently recruiting for a Senior Regulatory Affairs Program Lead to support our Surgery business. The MedTech Surgery Senior Regulatory Program Lead will be a responsible member of a Regulatory Affairs Team dedicated to developing and evaluating regulatory strategy in partnership with the assigned regulatory and clinical project leads.
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Title: regulatory affairs Company: Sanofi in Bridgewater, NJ
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