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Adheres to GB Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
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Plans and prepares regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports with moderate supervision.
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Maintain alignment with both US and International regulations and standards, as well as company quality systems. Demonstrated understanding and familiarity with relevant FDA and TUV regulations, as well as other clinical/regulatory requirements.
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If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
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The successful candidate must have experience managing Phase I-III trials and a strong understanding of clinical operations, GCP, and FDA regulatory environment. 5 years of direct site management (monitoring) experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through Phase 3 studies, both domestic and international.
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Must be well versed in FDA, EMEA and other international regulations for pharmacovigilance. Must be well versed in FDA, EMEA and other international regulations for pharmacovigilance. We are seeking someone with heavy pharmacovigilance experience to review PV system automation, regulatory oversight and patient safety reporting for vendor case management processing.
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Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH.
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Reporting directly to the Hiring Manager, the Product Surveillance File Manager will be responsible for reviewing complaints, analyzing qualitative and patient data, and making recommendations in alignment with FDA and international standards.
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Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
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Will be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.
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Ensure compliance with Safety standards, Sanitation and HACCP policies & procedures, federal, state and local regulations (OSHA, FDA, DOL) and all Papa John's International, Inc., policies & procedures.
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Minimum of 3 years of experience working with MES technologies such as Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, or Werum PAS-X. Additional Preferences: Exposure to international operations, diverse teams, global IT projects, or working in a global organization.
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Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities.
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Knowledge of FDA regulations, ICH and GCP guidelines concerning human subject research especially as they relate to computer systems/security, disaster recovery and regulatory compliance of research core labs.
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Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements. Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization.
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