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Job Title: Regulatory Affairs Manager CMC Biologics. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
$100 an hourExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Job Title: Senior Manager, CMC Regulatory Affairs, Biologics. Experience representing CMC regulatory affairs on regulatory and cross functional teams. Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
$100 an hourExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Top 3 Required Skill Sets: Significant experience in CMC Regulatory Affairs; strong verbal and written communication skills; experience in leading and preparation of regulatory submissions.
$105 an hourExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience. Unique Selling Point of this role: This role is a great opportunity to get experience in a CMC RA team, develop knowledge of Regulatory Affairs, and while working in data entry, may support the Team in other regulatory-related activities, such as supporting preparation of straight-forward submissions.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Senior Manager, CMC Regulatory Affairs, Biologics Location: Foster City, CA/Hybrid. Significant experience in CMC Regulatory Affairs; strong verbal and written communication skills; experience in leading and preparation of regulatory submissions.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Liaise with colleagues in Regulatory Affairs therapeutics teams. Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the international markets.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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10+ years of experience in Regulatory Affairs with a focus on CMC, ideally in oncology and/or immunology therapeutic areas. We are seeking a highly experienced Director of Regulatory Affairs for CMC to oversee and lead regulatory strategies in support of our oncology and immunology therapeutic programs.
$250,000 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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The Policy and Regulatory Affairs Intern will have the unique opportunity to work with the Policy and Regulatory Affairs State Team, supporting the deployment of the Zoox robotaxi and leading independent policy research and analysis on autonomous vehicle state-level regulations.
$7,500 a monthInternExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Liaise with colleagues in Regulatory Affairs therapeutics teams, Client local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Job Title: Senior Manager, CMC Regulatory Affairs, BiologicsDuration: months (we would like to start with months, with the potential to extend if the person is highly competent and a good resource for our team)Location: Remote but preference is to have a candidate available to be onsite at the Foster City, CA offices - days if possible RESPONSIBILITIES MAY INCLUDE.
$90 - $101.35ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Senior Manager, 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 3 days ago - UpvoteDownvoteShare Job
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Minimum 6 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.
Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
Full-timeExpandApply NowActive JobUpdated Today
Title: regulatory affairs specialist Company: Parexel in Foster City, CA
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