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5 + years of experience in global CMC regulatory affairs. Key responsibilities include leading the preparation and maintenance of CMC/quality sections for regulatory submissions, serving as the CMC regulatory representative on project teams, and providing regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product lifecycle.
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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.
$200,000 a yearFull-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Experience providing pipeline HEOR support (eg, prior close collaboration with clinical, product development, and regulatory teams) or prior US/Global Launch experience is strongly preferred. Partner with internal stakeholders to ensure appropriate customer facing dissemination of HEOR materials per regulatory guidance and internal SOPs.
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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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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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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.
$75,000 a yearFull-timeExpandApply NowActive JobUpdated Today - 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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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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Who We Are 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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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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Licensed mental health professional as confirmed by state regulatory/licensing board (e.g., LCSW, MFT, RN, or LPCC) from the state of operation. Licensed mental health professional as confirmed by state regulatory/licensing board (e.g., LCSW, MFT, RN, or LPCC) from the state of operation.
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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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Position Summary: Reporting to the Vice President, Medical Affairs, Field Medical Team Leader, we seek an experienced, science-focused, MSL to join our rapidly growing medical affairs team with the primary mission of increasing awareness with regards to the unmet need and pathogenesis of IgAN, and the role of targeting BAFF and APRIL as a potentially transformative, disease-modifying therapy.
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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. Position : Histology Technical Specialist/Histology Technician.
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Series 07 - FINRA, Series 63 - FINRA, Series 66 - FINRA. FINRA Series 7 & 63 licensed; Series 65 or 66 licensed and appropriate state registrations OR ability to acquire series 65/66 upon hire. We welcome those with experience in jobs such as Accounts Receivable Clerk, Accountant, and Financial Analyst and others in the Accounting and Finance to apply.
$75,000 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Title: sr in Burlingame, CA
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