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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs. Coordinate/author/review drug substance relevant sections of regulatory documents (IND, IMPD, NDA and MAA.
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Provide Regulatory Operations leadership during the implementation process of Veeva PromoMats in preparation for eCTD submissions to OPDP. Bachelor’s degree and/or Master’s degree with a minimum of 10 years relevant experience in pharmaceutical/biotechnology Regulatory Operations and project management.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Ultragenyx is seeking a highly motivated Associate Director Regulatory Affairs CMC, who is inspired to be a compassionate leader in the field of drug development for rare disease patients. Alternatively, 6 years pharmaceutical Regulatory CMC experience combined with 4+ years relevant pharmaceutical experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance or Quality Control.
$218,800 a yearFull-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Accountable for development and implementation of effective CMC regulatory strategies across products and product life cycles. Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Provide services to individuals according to, DDS, DMH, MassHealth, HUD, DPH, CARF, all applicable regulatory standards, and Bridgewell policies and procedures. Maintain daily and monthly progress notes, shift checklists, and other program documentation according to DDS, DMH, and all applicable regulatory standards.
$19.35 - $19.95 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Expertise in regulatory submission structure and content (e.g. IND, CTA, MAA, NDA, BLA). Dragonfly Therapeutics is seeking a Head of Regulatory Affairs, title commensurate with experience, and reporting directly to the COO, to lead our Regulatory Affairs organization.
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Utilizing the nursing process, the ECT/TMS/Ketamine nurse is responsible for providing for immediate and long-term nursing care needs of patients receiving ECT/TMS/Ketamine within the standards of the department, hospital and regulatory agencies.
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Regulatory Compliance: Advise and counsel business clients on a range of compliance and regulatory issues, including privacy & product security laws, public procurement laws, domestic preference sourcing requirements, anti-corruption & anti-bribery laws, antitrust law, export controls and others.
$167,000 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Works in close collaboration with the Project Management and CMC teams and related functions, including discovery, non-clinical development, formulation development, analytical development, Quality Assurance and CMC Regulatory affairs.
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Manage internal investigations related to regulatory and policy violations specific to Global Trade compliance areas (ITAR, EAR, US CBP, OFAC, ATF, and Antiboycott) Familiarity and working understanding of USML and CCL classification determination processes, export and import regulatory requirements.
$221,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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This position requires a strong understanding of both immunoassay development and manufacturing processes, with a focus on maintaining assay integrity, optimizing efficiency, and ensuring regulatory compliance.
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The Clinical Pharmacist Consultant is responsible for the evaluation and reporting of patient medication regimens, ensuring appropriateness, effectiveness, and safety, considering quality of life, adverse issues, cost and regulatory compliance.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Experience authoring technical documents (process development, tech transfer, batch records, IND supporting documents) and supporting drafting of CMC sections of regulatory submissions (IND, IMPD, BLA.
Full-timeExpandApply NowActive JobUpdated 1 month ago
regulatory job Company: Abbott in Bedford, MA
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