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Partner with CMC Regulatory and SMEs to assess compliance with regulatory guidelines and industry best practices for US and EU markets to ensure appropriate quality processes and procedures are implemented for commercial cell-therapy GMP manufacturing, at-scale and in-compliance.
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Knowledge of the FDA regulatory process and/or experience with an FDA approved medical device. Knowledge in assembly processes like Film lamination, Thermo-Compression Bonding, Surface-mount circuit assembly, wire-bonding, etc.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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Stay updated on regulatory guidelines and industry standards related to patient-centered research and psychometrics. Knowledge of health outcomes research methodologies, regulatory requirements, and best practices in patient-centered outcomes assessment.
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Reporting directly to the VP of Medical Affairs, the MSL is responsible for developing and maintaining professional peer-to-peer relationships with key medical experts in ophthalmology/retina. Advanced and hands-on working knowledge of relevant regulatory and compliance issues related to MSL responsibilities.
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Established network within Oncology or BioPharm R&D, or Alexion Rare Disease Unit, either the business or corporate affairs/communications teasm. Established network within Oncology or BioPharm R&D, or Alexion Rare Disease Unit, either the business or corporate affairs/communications teasm.
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Complete the authoring of technical reports in collaboration with QA / RA / MSAT / ARD teams and assist in submission to regulatory agencies such as FDA. Experience supporting of regulatory documentation or filings.
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If applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations at various steps (site qualification, site recruitment.
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Experienced in communicating with regulatory and licensing offices and official certification authorities. Current certification as Medical Technologist, Medical Laboratory Scientist, or similar; ASCP certification strongly preferred.
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Conducts library searches Performs administrative support duties as required Verifies accuracy of study forms Updates study forms per protocol Prepares data for analysis and data entry Assists with formal audits of data Documents patient visits and procedures Assists with regulatory binders and QA/QC procedures.
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Stay abreast of industry and regulatory standards and GCP requirements related to TMF and provide strategic guidance. Expert knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines and regulatory requirements.
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Be ready to participate in quality systems, engineering, mfg, regulatory activities, etc. knowledge of manufacturing processes such as plastic injection molding, ultrasonic welding, etc. The job responsibility will primarily include developing, designing, troubleshooting manufacturing SOP's, and microfluidics based systems.
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Maintain current knowledge of broad scientific advances related to full range of radiopharmaceutical agent discovery and development including competitive, scientific and regulatory trends. Communicate effectively as an official Lantheus spokesperson in a variety of settings (e.g. professional societies, regulatory bodies.
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In this role, in collaboration with key stakeholders in Technical Operations, Regulatory Affairs and extended Quality (ie. QC, Supplier Quality), you will provide Quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines at GTMF and/or contract manufacturing organizations (CMO.
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Collaborate with functional areas including clinical pharmacology, regulatory affairs, clinical development, CMC, etc. Familiar with ICH, EU, and FDA regulatory guidance documents for nonclinical drug development.
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regulatory affairs jobs Title: sr regulatory affairs associate in Lexington, MA
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