- CSL Plasma (Fairfield, CA)
- …This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and ... of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate… more
- Kelly Services (Petaluma, CA)
- …to bringing innovative antimicrobial solutions to market. The company combines device and drug expertise, operates under strict FDA regulations, and is scaling ... and provide feedback to product teams. + Ensure trial data aligns with FDA requirements and supports regulatory filings. **Qualifications** + Bachelor's degree… more
- Abbott (Alameda, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations applicable...industry + Min 8 years auditing per ISO and/or FDA standards. + Knowledge of MDD, CMDR, MHLW, TGA,… more
- Actalent (Newbury Park, CA)
- …+ Gas Chromatography (GC) + Spectroscopy + cGMP Compliance + ICH Guidelines + FDA Regulatory Compliance Preferred Attributes + Familiarity with cGMP, ICH, and ... review of analytical data for starting materials, intermediates/in-process controls, drug substances, and drug products, including batch...FDA regulatory guidelines. + Experience working with… more
- Kelly Services (South San Francisco, CA)
- …preferred. + Deep expertise in cGMP standards, with strong working knowledge of US FDA , EMEA, and ICH regulatory guidelines. + Proven ability to manage CDMO/CRO ... manufacturing relationships. + Track record of authoring, reviewing, and supporting regulatory documentation for global drug development. + Outstanding… more
- Amgen (Thousand Oaks, CA)
- …best practices that fit Amgen's business needs are effectively applied + Represents Drug Substance Technologies as a scientific, regulatory and technical expert ... knowledge of GLP and GMP activities + Clearly understands and applies knowledge of regulatory requirements ( FDA , ICH, USP, etc.) to completion of projects +… more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary ... Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains… more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Job ... quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board...all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review… more
- Abbott (Sylmar, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... systems are developed, validated and maintained in compliance with regulatory and business procedures. As a global leader in...GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. + Knowledge of FDA 21 CFR part 820, 21 CFR part 11,… more
- Gilead Sciences, Inc. (Foster City, CA)
- … substance and drug product. + Proven track record in drafting regulatory documentation at all stages, including **IND, BLA, and PAS** filings. + Demonstrated ... development from early development to commercial launch, filing experience with FDA /EMA, and in-depth technology understanding for biological products are the key… more
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