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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
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Sr. Regulatory Affairs Specialist-CT/AMI. Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders.
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Large MLTC program with locations around NYC, is currently seeking an experienced Regulatory Affairs Associate to join their dynamic and dedicated team. Regulatory Affairs Associate – MLTC Program - Hybrid.
$125,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
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The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
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You will provide global product stewardship and regulatory affairs services for a line of chemical products that support Videojet printers. Manage our SDS, label, and regulatory affairs systems.
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We are seeking a global Executive Director, Regulatory Affairs, Cell Therapy (level determined by candidate experience) reporting into the SVP Clinical Operations who will serve as the strategic lead representing regulatory affairs expertise managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.
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As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U.S. and other regions (Asia/Pacific, Latin America, Africa, Europe, and Canada.
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The Director, Federal Regulatory Affairs will report to the Managing Director, Federal Regulatory Affairs and will provide centralized management of Constellation’s advocacy at the Federal Energy Regulatory Commission (FERC) and other organizations, as appropriate, including all communications with FERC, internal development of positions, participation in proceedings, preparation and filing of pleadings, and informal advocacy.
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Job Description PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management.
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Regulatory Affairs Manager *PC Regulatory Affairs - Waltham MAAt Miltenyi Biotec, 3, employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies.
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Director, CMC Regulatory Affairs. 15+ 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.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Reporting directly to Executive Director, Regulatory CMC. Your expertise will play a pivotal and visible role in advancing CMC. Directs and coordinate regulatory activities of external consultants in consultation with Global Executive Director or designee.
$197,000 - $232,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The Senior Regulatory Affairs Specialist will be responsible for projects by leading biologics CMC regulatory submissions, reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.
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Block is looking for an experienced policy and regulatory strategist to serve as our Head of Regulatory Affairs. Maintain fluency on a variety of regulatory and policy issues at the intersection of financial and technology policy, including financial regulation, consumer protection, tax, cryptocurrencies, AI/machine learning, intellectual property, and privacy.
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regulatory affairs jobs Title: sr director Company: Usaa
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