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Reporting to the Head of Regulatory Affairs, this individual will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and of high quality.
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Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development.
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Lead early and late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
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In-depth understanding of CMC regulatory requirements and experience with compiling CMC sections for regulatory filings. This position collaborates closely with cross-functional team members, including analytical development, quality assurance, manufacturing and process development, regulatory and clinical operations.
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Reporting to Clinical Research Manager for Radiation Oncology, the Clinical Research Coordinator Associate will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to manage data, enroll and follow patients on trial and assist with regulatory and financial requirements of the trials.
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Author/review and/or coach team members to author CMC regulatory sections of IND/INDa. Contribute to regulatory strategies and support associated agency interactions and product-related inspections.
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We are looking for an experienced and innovative credit attorney to join our product and regulatory counsel team as Senior Counsel, reporting to the Deputy General Counsel and VP, Regulatory & Product at Robinhood.
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The Government Programs (GP) Team within Channel and Contract Management is responsible for managing the complexities of Government Contracting and Price Reporting to enable patient access through the federal drug programs (Medicare, Medicaid, 340B, Veterans Affairs and Department of Defense Federal Supply Schedule & TRICARE.
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Strong knowledge of GMP quality systems and regulatory requirements for drug development. Prepare and review CMC analytical sections of regulatory submissions (IND, BLA, NDA, MAA) and respond to regulatory requests for information.
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Prepare and provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (, IB, DSUR, PSUR, regulatory responses)Participate or lead as needed the review and assessment of new opportunities and ESRs. Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.
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Combined with Charles River’s integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization.
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Job Title: Regulatory Affairs CMC – Data Administrator Contractor. Work is performed under the general supervision of more senior Regulatory Affairs CMC Systems professionals.
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Should have experience with Veeva Vaults, experience with the RIM Vault preferred. Should have familiarity with web-based Electronic Data Capture (EDC) and data management systems. Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports.
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To Clinical, Manager, Monitoring, Operations, Regulatory Affairs, Project Management, Healthcare. Works cross-functionally with other Guardant Health departments (such as Bioinformatics, Clinical Operations, Regulatory Affairs, Client Services, etc.
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Provide guidance and support to R&D scientists on histology techniques and uphold laboratory safety and regulatory compliance. Familiarity with regulatory compliance and LIS systems. Certification as a Histotechnician (HT) or Histotechnologist (HTL) by the American Society for Clinical Pathology (ASCP) required.
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regulatory affairs jobs Title: sales representative Company: Vector Marketing in San Mateo, CA
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