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Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Liaises and negotiates with US FDA as needed for all aspects pertaining to drug development including novel regulatory pathways for the company's gene therapy products, resolution of key regulatory issues and to expedite approvals of products.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Associate Director of Regulatory Affairs (RA) Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with Labeling Management Team (LMT) and Executive Labeling Committee (ELC) as appropriate, and participating in label-related Health Authority negotiations.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Lead 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.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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This position will lead the implementation of Quality processes and Inspection Readiness Activities, assist with the management of the audit program and partner with key clinical cross-functional groups (e.g., Clinical Operations, Biometrics, Regulatory Affairs) to ensure compliance of Zentalis’ Clinical Development Programs and continuous process improvement.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Ensure alignment of labeling strategy with overall regulatory and program strategy by collaborating with internal stakeholders including Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, and Supply Chain.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Understanding of scientific principles and regulatory/quality systems relevant to drug development. Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identify issues; offers creative solutions and strategies, including risk mitigation strategies.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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We are seeking an Associate Director/Director of Regulatory Affairs to join the company. Solid working knowledge of the drug development process and regulatory requirements in the US is required with global experience preferred.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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As a Clinical Scientist/Associate Medical Director, Clinical Development, this candidate will work cross-functionally to develop strong relationships with key stakeholders within Clinical Development, Clinical Operations, Regulatory Affairs, and Pharmacovigilance to support ongoing clinical trials and the lifecycle of the drug candidate.
RemoteExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions (such as Drug Product Development, Drug Substance Development, Analytical/QC, and Quality teams.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
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Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product information and labeling updates, including other Development teams, Legal, Commercial, and external regulatory agencies.
$177,905 - $230,230 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago
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