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Associate Director, Regulatory Affairs Advertising and Promotion page is loaded. Associate Director, Regulatory Affairs, Labeling. Associate Director, Regulatory Affairs Advertising and Promotion.
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10+ years of pharmaceutical/biotech drug development experience with 5 + years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
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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.
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Minimum 8 years of relevant experience in CMC Regulatory Affairs. Work experience in Regulatory Affairs or related discipline. 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.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
$177,905 - $230,230 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Partnering with team members and other functional areas including Regulatory Affairs, Clinical Pharmacology, Clinical Development, Quality Assurance, Legal, Data Management and Biostatistics to perform study related activities.
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We are currently seeking a Regulatory Affairs Associate Director to join our growing regulatory team. Associate Director - 5 - 7 years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Sr Director, CMC Regulatory Affairs –Biologics. Associate Director, Quality Engineering - Combination Products, Tech Transfer and Commercial. Perform MDR evaluations and document written justification to support reportable and non‑reportable regulatory decisions.
$154,020 - $199,320Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Experience working cross functionally with greater CMC/Technical Operations team, Quality Assurance and Regulatory Affairs. Contribute drug product expertise in support of global CMC regulatory strategy.
$194,000 - $237,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The Senior State Policy and Regulatory Affairs Associate will support Zoox’s state policy portfolio, providing important project management, public policy analysis, and help to implement Zoox’s state policy strategy.
$100,000 - $161,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Adicet Bio is seeking an exceptionally talented and motivated individual to join our team as a regulatory associate I/II. This position will be responsible for supporting the Sr. manager of regulatory affairs and assisting in developing and executing regulatory activities in support of the CMC, nonclinical, and clinical development for our early development pipeline products within the Regulatory Affairs department.
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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.
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Job Description Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
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Proven experience in the generation of relevant regulatory sections of IND filings. We are seeking an experienced and highly motivated small molecule formulation scientist with a proven record of sustained laboratory achievement and innovation to join our growing Department of Pharmaceutical Sciences (PharmSci/CMC) at ORIC Pharmaceuticals.
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Partners with all functional areas (translational research, CMC, regulatory affairs, clinical development, clinical operations, and pharmacovigilance) to build and maintain integrated project timelines, track progress, resolve conflicts, and communicate current project status.
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regulatory affairs associate jobs in San Mateo, CA
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