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Firm Type: Law Firm, Experience: 5 Years, A law firm is seeking an FDA Regulation Associate Attorney for their office in New York City, NY. This role involves providing FDA regulatory counseling to cutting-edge technology companies and supporting corporate and contracting teams in MAs, asset deals, IPOs, and other complex transactions.
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Keywords: Regulatory, IND, CTA, SharePoint, Gene Therapy, Cell Therapy, Biotechnology, FDA, Pharmaceutical, Regulatory Submission. · Detail-oriented with expertise in FDA submission requirements and familiarity with cell and gene therapy regulatory standards in major markets like the US and EU.
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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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You've acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K's, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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Familiarity with regulatory requirements for bioprocess development and manufacturing (e.g., cGMP, FDA guidelines) The Capital Area Division (CAD) of Applied Research Associates, Inc. (ARA) is seeking a Synthetic Chemist / Chemical Engineer to design and develop continuous flow processes to produce various synthesized molecular products.
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Interface with all regulatory agencies' PDA, FDA, as well as organic, koshering agencies, halal, and customers. The Quality Assurance and Regulatory Compliance Manager will be responsible for the establishment, maintenance, planning, directing and coordinating of programs, procedures and processes necessary for manufacturing food ingredients in accordance with local, state and national regulatory agencies.
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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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The Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates.
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The Clinical Research Quality & Regulatory Specialist plays an integral role in the data integrity and regulatory compliance of pharmacy services related clinical research. Works closely with the Senior Research Training and Compliance Coordinator-Pharmacy to analyze internal audits, refines processes to ensure the quality of data integrity, and maintains regulatory compliance.
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The IRB Regulatory Consultant will work with investigators, study staff, local and Central Institutional Review Board, and the sponsor of the clinical trial to ensure that the studies are conducted in compliance with ICH GCP, the FDA, IRB, and other regulatory requirements.
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Pharmaceutical industrial engineering knowledge (pharmaceutical design, development, manufacturing, and regulatory requirements) to optimize technical transfer from lab-scale to kilo lab/pilot plant production; Implement hazard operability analysis and risk assessment skills to draft batch records and safety reports; Analyze lab and production data using NMR instrumentation, data interpretation, Chromatography to ensure FDA regulatory compliance and maintain quality standards.
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As a Senior QA Associate, Compliance/QA Lead , you would be responsible for ensuring product compliance to established cGMPs, to meet safety and quality standards for FDA Regulatory and customer requirements by adherence to Standard Operating Procedures (SOPs.
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Turner Dairy Farms, a family-owned company, is looking for a career-minded individual to safeguard product safety and quality while meeting company and regulatory standards. SQF Practitioner•Maintain contact for PA Department of Agriculture, FDA, USDA•Maintain Master Cleaning and inspection program.
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Understand, display knowledge and supervise execution of FSQA programs including, but not limited to BRC systems, HACCP, sanitation, pest control, good manufacturing practices, foreign material control, customer complaint, deviation investigation process, Root-cause analysis, traceability, internal audit program, trainings, food defense and security to comply with all company, Customer and USDA/FDA regulatory requirements.
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Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP). This position will work closely with the Vice President of Biostatistics and Executive Director of Data Management and Statistical Programming and other members of the clinical, pharmacovigilance and regulatory affairs teams to provide programming support across all programs.
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fda regulatory jobs Title: quality manager regional
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