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Reporting to the Senior Manager of Medicare Regulatory Compliance, the Medicare Regulatory Compliance Specialist will support the oversight and management of the Medicare Compliance Program.
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Sr. Specialist Regulatory Affairs. Manage regulatory affairs activities including preparation of Annual Report, Change Control assessment. Minimum of 5 years of pharmaceutical industry experience, of which minimum of 3 years in regulatory affairs.
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The Regulatory Affairs Specialist provides direct Worldwide Regulatory support to lifecycle management and new product development/new product introduction international product registrations.
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The Labeling Specialist must be accustomed to working within established timelines and have a high attention to detail. Scope, redline and update labeling and documentation to support labeling changes.
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The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada.
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Regulatory and QA Specialist. Prepare regulatory documentation for flavors and essential oil products - SDS, Allergen statement, Natural status, GMO, Prop 65, flavor product Ingredient listing, etc.
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Proactively coordinate with the Clinical Trial Team to establish the priorities in accordance with applicable project plans, company standard operational procedures (SOPs), GCP guidelines and regulatory requirements.
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The Specialist in Regulatory Affairs will be assigned to the Risk Analysis and Strategy group. Specialist, Regulatory Affairs. Regulatory Affairs, Compliance, Product Development, Law, Legal, Research.
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Prior FDA regulatory approvals for software and apps. Prior FDA regulatory approvals for software and apps. We specialize in enhancing currently marketed drugs with well-known pharmacology profiles.
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We are seeking a versatile and strategic Regulatory Affairs Specialist to join our dynamic Reed Tech Life Sciences Professional Services. Regulatory Affairs Specialist.
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Position : Regulatory Affairs Specialist. Ensures Regulatory compliance within KEDPLASMA organization to cGMP, Standard Operating Procedures and other applicable Standards and Protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.
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Regulatory experience (SEC, FINRA, CBOE, NFA, CFTC, etc.) The Firm's Regulatory Group is housed within its Legal Department. This hire will be a member of the Firm's Regulatory group which is responsible for exam oversight, branch inspections, regulatory change tracking, governance related tasks and additional ad-hoc tasks.
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Regulatory Affairs US Biologicals labeling specialist. Support regulatory filing submissions with the USDA for both domestic and international product packaging. Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance.
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The Senior Regulatory Affairs Specialist will be responsible for performing a wide variety of tasks to. Ensures documentation related to regulatory matters, process, and product / label change control.
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Ensures regulatory compliance of technical documentation in local PLM system and corresponding product registrations with FDA and EU Notified Body. Updates and maintains product registrations with US FDA and EU Notified Body to assure compliance with applicable global regulatory requirements.
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regulatory job Title: regulatory affairs specialist in New York, NY
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