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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
$199,320 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience working with and building strong relationships with cross-functional departments in business, marketing, hardware and software engineering, product and project management, process and analytical development, regulatory and quality.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Author regulatory submissions and serve as a pharmacokinetics/clinical pharmacology subject matter expert during interactions with regulatory agencies. As a Pharmacokinetics/Clinical Pharmacology Principal Scientist, you will utilize your experience to further characterize the novel kinetics of our new therapeutic modality and build complex models that inform study designs and decision-making throughout the drug development process.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Global Regulatory Strategy Head’s organization is accountable for all CMC regulatory activities in order to guarantee that all global products manufactured at or on behalf of Roche or supplied to Roche (DS, DP and packaging operations) fulfill and maintain our right to operate by meeting Regulatory expectations.
$408,450 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical pharmacology study start-up/execution/close out, PK-PD and related analysis, interpretation and reporting, and support of regulatory filings.
$230,230 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Lead and support CMC regulatory filing strategies to meet global health authority requirements for cell therapy assets. Comprehensive understanding of regulatory requirements and facility design for manufacturing operations.
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Licensed mental health professional as confirmed by state regulatory/licensing board (e.g., LCSW, MFT, RN, or LPCC) from the state of operation. Free CEUs, free Supervision for BBS Associate License, coaching and mentorship.
$136,029.34 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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.
$20 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The optimal candidate participate will lead the department and also collaboratively work across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Responsibilities Key Areas of Responsibilities:Oversees Engineering, Biomedical Engineering, Security, Telecommunications, and EVS. Oversees the physical plant and maintains it to meet regulatory requirements.
$168,475 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This role requires collaboration at the Team Leadership level with the Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle.
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Must meet all state required conditions of employment as set forth by funder and regulatory body including fingerprint and child abuse index clearance, TB/health physical exam, a valid California driver’s license, and a clean driving record.
$250,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory Affairs. The Associate Director, Analytical Regulatory Science, collaborates with product.
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Familiarity with data protection laws, including GDPR, CCPA, and HIPAA.Experience in incident response, risk management, and regulatory compliance in the cybersecurity domain. Regulatory Compliance: Monitor and interpret information security and cybersecurity regulations, and other relevant laws.
$321,700ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Stay current with regulatory requirements on CDISC and clinical regulatory programming standards including therapeutic area-specific standards. Thorough knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidelines.
$286,300 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago
regulatory job Title: sr regulatory affairs associate in Burlingame, CA
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