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Title: USA - Regulatory Affairs Ops Specialist I. Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents. Solid understanding and experience and interpretation of regulatory requirements, with particular Client on the US region.
$28 - $32ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. Title: Sr Regulatory Affairs Specialist.
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Job DescriptionJob DescriptionSalary: Reporting directly to the Licensing and Regulatory Affairs Manager and indirectly to the Chief Executive Officer, the Environmental Health & Safety (EHS) Specialist will facilitate and maintain the Companys EHS programs and procedures and serve a subject matter expert for safety regulations and best practices.
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Position Summary: The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory staff to submit regulatory filings. Qualifications Education and Experience: Bachelor's degree with 3-5 years of relevant experience in regulatory affairs in an IVD manufacturing environment; Or, a master’s degree with up to 2 years of relevant experience Knowledge, Skills, and Abilities: Excellent attention to detail and organizational skills are required.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada.
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The Senior Regulatory Affairs Specialist will be responsible for performing a wide variety of tasks to. Ensures documentation related to regulatory matters, process, and product / label change control.
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As a key cross-functional constituent, this employee will work closely with functions across the organization - Marketing, Regulatory Affairs, Clinical Development Engineering (CDE), Global Access Value Economics (GAVE), and commercial functions to ensure scientific accuracy and meet business objectives.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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We specialize in opportunities within Computer System Validation (CSV), Regulatory Affairs, Quality, Clinical Development & Drug Safety, Pharma BA and Compliance. Benefits: 401(k) Bonus based on performance Competitive salary Dental insurance Flexible schedule Health insurance Opportunity for advancement Relocation bonus Training & development Tuition assistance Vision insurance Wellness resources Validation Associates LLC is a specialist pharmaceutical recruitment & staffing consultancy that focuses on providing an expert, knowledgeable and professional service to candidates and clients in life sciences.
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Support Regulatory Affairs in identifying, investigating, and documenting complaints that are reportable under US and International Regulations. Manage the Internal Audit Program, perform internal audits as necessary, assist in resolving observations, and provide support for audits and inspections from Regulatory Authorities.
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The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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O Overseeing authoring and reviewing of regulatory documents o QC submission documents. Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
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Interface with representatives from key functional groups including, but not limited to, Marketing, Sales, Clinical Research, R&D, and Regulatory Affairs, to drive success of MicroVention products, development, and other programs supported by the Global Market Development team.
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Key interfaces include: Packaging Engineering Team, Quality, Operations, Regulatory Affairs, and Packaging sites/CMOs. Support changes to packaging processes and transfers. Responsibilities This Senior Specialist, Packaging Change Control serves on packaging project teams and assists technical staff with packaging documentation and change controls.
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Minimum of two (2) years of drug supply chain or pharmacy regulatory affairs experience. Pharmaceutical State Licensing Application Specialist - Puerto Rico. Pharmaceutical State Licensing Application Specialist - Puerto Rico.
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Specialist Regulatory Affairs (Poultry) Specialist Regulatory Affairs page is loaded. Specialist Regulatory Affairs. Global Regulatory Affairs (GRA) is accountable for licensing and maintaining pharmaceutical and biological animal health products globally.
ExpandApply NowActive JobUpdated 11 days ago
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