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Experience or having worked for a Federal or State regulatory or legislative body potentially including Congress, the FCC, a state legislature or a Governor’s office. Six years of relevant experience in corporate communications, public relations, cyber and corporate security, political campaign experience or crisis communications.
$202,000 a yearFull-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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The Director of Statistical Programming Medical Affairs provides leadership to the group in Medical Affairs, including Health Economics and Outcomes Research (HEOR). Extensive experience in medical affairs/post-approval area and execution of project user requirements, system design, validation plans, operational and performance protocols, research, and development of applications and toolkits for end-users.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Build a team of R&C consultants across experience ranges in Financial Risk, Non-Financial risk, financial crime, Regulatory compliance (e.g. BSA, Basel). Strong understanding of Regulatory compliance in the areas of Investment banking, Asset management, Wealth management, market infrastructures, P&C insurance, L&A.
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At least 2-3 years of experience in CMC regulatory affairs supporting early and late-stage allogeneic gene-edited product development. Legend Biotech is seeking an Associate Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Work with Scientific Affairs and Public Health Teams to conduct implementation clinical research. Knowledge of regulatory requirements and ethical guidelines pertaining to clinical research.
$217,350 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high-quality technical reports.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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This individual will be responsible for delivering CMC documentation (Dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
$41.8 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The position interfaces with experts in Process Development, Analytical Development, Manufacturing Sciences and Technology, Operations, Quality and Regulatory Sciences. Experience with regulatory documentum software (CARA, eSub, etc) is strongly preferred along with proficiency in compliance ready standards for final publication.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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8+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC. Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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The role will also include working closely with our Medical and Clinical Affairs (MACA) team to recommend clinical and health economic studies and health economic data analysis as well as our Research and Development teams as we develop new products within the AWC portfolio.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Through scientific exchange, the MSL will communicate and advance the scientific platform aligned with the overall medical communications and medical affairs strategies. Attend medical/scientific meetings to represent Zealand Medical Affairs with KOLs and other HCPs, strengthen individual expertise as well as capture, integrate, and summarize information of strategic interest.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Experience working with in-house counsel, Finance, Comptrollers, CFO, Labor Relations, and external legal counsel to ensure regulatory compliance for all benefit programs, plans, policies and procedures.
Full-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Client locations or contract manufacturing organizations (CMOs), or alliance partners.
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The Clinical Systems Analyst will assist the Senior Director of Clinical and Development Systems in planning, directing, and coordinating software projects and support activities within the Drug Safety, Pharmacovigilance, Regulatory, Clinical Operations, and Quality Assurance groups.
Full-timeExpandApply NowActive JobUpdated 1 month ago
regulatory affairs jobs Company: Mallinckrodt Pharmaceuticals in Bridgewater, NJ
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