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The ideal candidate will have a deep understanding of food manufacturing processes and regulatory requirements, including SQF, HACCP, FDA, Quality, GMP, Batch Record Review, QMS, and Dairy.
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The Regulatory Affairs Manager monitors regulatory issues within designated areas and identifies opportunities to engage with government agencies including those within the Department of Health and Human Services (HHS) to further advance the mission and priorities of the Immune Deficiency Foundation (IDF.
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Job Overview: A law firm in Washington, D.C., is seeking an FDA - Health Care Associate Attorney with 4-6 years of experience and a strong background in drug and medical device regulatory compliance issues, particularly in current good manufacturing practice (CGMP) matters.
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Experience in engaging regulatory professionals for navigating the product development process through FDA regulatory submission, scaling manufacturing, and post market surveillance.
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Interact and negotiate with regulatory agencies / Notified Bodies to support product life cycle management, including FDA for Class II and III Pre-Submission Meetings and PMA submissions, Health Canada for Class III/IV submissions, and EU MDR Class I - IV submissions and change notifications.
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Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements. Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals.
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Regulatory Compliance: Ensure that all assay development activities adhere to relevant regulatory standards and guidelines, including but not limited to FDA, ISO, and CLIA. We are supported in this mission by top Silicon Valley and New York venture firms that are leaders in the healthcare space with extensive experience in supporting precision medicine companies such as Foundation Medicine and Guardant Health.
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Clinical chemistry, immunoassay FDA & EU or Class III medical device experience with b road knowledge of medical device industry, regulatory requirements, and frameworks. Comprehensive knowledge of FDA & EU IVD regulations experience including a conversant knowledge of evolving China regulatory expectations.
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Must have 2 years experience with planning, executing, monitoring and reporting of activities for FDA regulatory compliance projects of GxP systems; Performing Root Cause Analysis for deviations from process and agreed metrics; Performing risk management; Working with GxP, GAMP, GDP, 21 CFR Part 11, Annex 11, CSV, CSA, FRA, Risk Based Validation.
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Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.), Microconsult Inc., and Micro Quality Labs Inc. Certified Group provides laboratory testing and regulatory consulting services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, tobacco, nicotine, cannabis, hemp, and other industries.
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The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of regulatory activities required of an IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio.
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Provide legal counsel and guidance to clients on FDA regulatory matters related to regulated products. 5-10 years of experience in FDA regulatory law, preferably with a focus on counseling companies with FDregulated products.
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Be familiar with FDA regulatory requirements on data integrity and data governance on computerized systems. Familiar with FDA regulatory standards, possessing the capability to handle changes, deviations, CAPA (Corrective and Preventive Actions), and similar tasks.
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Understanding the systems landscape and business operations end-to-end to best lead the ERP, IT systems, and FDA regulatory requirements. - Manage quality control and regulatory requirements to ensure FDA compliance and CGMP (current good manufacturing practices.
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Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the pharmaceutical/biologics industry.
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