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6-8 years of relevant experience in the biopharmaceutical industry, with at least 5 years focused on CMC Regulatory Affairs for biologics. Experience in managing interactions with regulatory health authorities and submitting CTA/IND and BLA/MAA filings, particularly related to gene therapy.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Minimum seven (7) years customs brokerage, customs consulting, regulatory or similar professional services is required. Actively manage and continuously develop a team of compliance professionals providing day to day support of regulatory and compliance-based inquiries.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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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 and small molecules.
ExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Master’s degree in a scientific field is required with emphasis on regulatory affairs and in the dietary supplements category. Position Title: Regulatory Affairs Manager. Seven -plus years of experience in a regulatory role having oversite to compliance and involvement in QMS in the nutrition and dietary supplement categories.
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Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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This pivotal role necessitates close collaboration with cross-functional teams, including Clinical Development, Regulatory Affairs, and other departments to foster and uphold a robust drug safety culture.
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Engage with and lead advocacy efforts with regulators in Asia and EMEA on Public Cloud in partnership with Government Affairs and Regulatory Engagement teams. Leverage data to examine impacts to Customer Experience and Regulatory breaks.
ExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Collaborate with Analytical Chemistry, EH&S, Engineering, Project Management, Quality Assurance and Regulatory Affairs to ensure strong working relationships with all partners and employees.
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Consult collaboratively with jurisdictional Regulatory Affairs and other internal teams to support emerging technology-related rulemakings and growth-related efforts through the development of regulatory recovery strategy models, RIM tests, and other analysis to determine optimal regulatory strategies around these business opportunities and affecting successful regulatory reviews and approvals.
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We are hiring a Senior Regulatory Affairs Specialist for our Diagnostics Regulatory Affairs team who will be responsible for new product development, on-market, and international regulatory activities associated with US FDA, EU Notified Body, and other international regulatory agencies.
ExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Position Title: Senior Regulatory Affairs Associate, Product Development. In-depth understanding of Regulatory Affairs concepts and should be familiar with regulations/guidelines governing the development of diagnostic products and claims in labeling.
ExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Reporting to the our CMC Executive Director, the CMC Regulatory Technical Writer, Associate Director/Director will be responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.
ExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Senior Counsel, Regulatory Affairs (Americas) will provide critical legal support for laws impacting the beauty industry and other regulatory-related matters across Wella Company's portfolio of products.
ExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies.
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Current critical need is toward a new VP of Quality & Regulatory Affairs as a focal point toward all PMA submission activity as well as spearheading company quality management system design and implementation.
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regulatory affairs jobs in New Orleans, ID, Nevada
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