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Reporting to an Associate Director, CMC Regulatory Affairs, the successful candidate will work independently and collaborate cross functionally to provide guidance to the CMC subject matter experts and manage and execute CMC regulatory submissions to facilitate the global development of Avidity compounds.
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Maintain working knowledge of the policies and procedures of the Human Research Protections Program HRPP and of the VA Human Subjects Office review these policies and procedures under the general supervision of the Medical Director of Regulatory Affairs and as needed, consult with HRPP analysts and the CTO Quality Assurance Manager to resolve issues.
$34 - $55 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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They will also be responsible ensuring strong cross-functional alignment in the flawless execution of strategy and promotional tactics working in close collaboration with partners, especially Patient Services, Patient Advocacy, Corporate Communications, Marketing Operations, Sales Training, Market Research, Regulatory, Legal, Medical Affairs, Regional Marketing Managers, Managed Markets, Regulatory other members of the brand team, and agencies.
$272,775 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
$315,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Regulatory Affairs Specialist will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies.
$127,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Education & Experience Bachelor's Degree required in the life sciences or engineering with a minimum of 5-8 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry.
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8+ years of experience in quality assurance, regulatory affairs, compliance roles, and EHS program management within the pharmaceutical or biotechnology industry, including expertise in FDA (GLP), USDA, AAALAC, OLAW, DEA, OSHA, and environmental health regulations.
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You partner with functional leaders and team members to drive Ops critical path program activities/ resources/ costs across all departments including:Technical team (Mechanical, Process, Electrical, Software, and Automation Engineering), Manufacturing, Contract Manufacturing, Procurement, Master Planning, Logistics/Distribution, Facilities, EH&S and others (Regulatory Affairs, Ops Quality, Finance, IT, etc.
$214,400 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Regulatory Affairs, biologics, biotechnology, pharmaceutical, regulatory submission, FDA, EU. 4+ years of experience in Regulatory Affairs or related fields within the Biologics, Biotech, or Pharma.
$40 an hourPart-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Seeking a detail-oriented (preferably experienced) Regulatory Affairs Senior Specialist to join our regulatory dept. Collaborate with hospital leadership and clinical teams to develop and implement regulatory strategies , ensuring that hospital policies are aligned with current laws and regulations.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Can act as regulatory affairs CMC liaison with partner companies and contract manufacturers. Minimum 10 years of progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry required.
$220,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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We are hiring a Senior Regulatory Specialist for an established in-vitro diagnostics company in San Diego, CA. This is hybrid on-site role 3 days per week and requires at least 5-7+ years of hands-on Regulatory experience including 510(k) authorship.
$130,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Genalyte, Inc., a leader in innovative diagnostic solutions, is seeking a highly skilled and motivated Senior Regulatory Affairs Specialist to join our dynamic team. Senior Regulatory Affairs Specialist will assist in regulatory submissions, interpret regulations, and provide regulatory guidance.
$120,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Job Type: Full time Job Title: Associate Director of Regulatory Affairs Location: Onsite - San Diego Salary Range: $150,000 - $170,000 Position Summary: The Associate Director of Regulatory Affairs will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and De Novo submissions.
$170,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
$174,400 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago
regulatory affairs jobs in San Diego, CA
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