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Primary responsibilities are to support Shell Energy's wholesale/retail trading/origination businesses and Shell Renewable and Energy Solutions related businesses through external advocacy for competitive markets, communicating regulatory changes and impacts of regulatory changes to commercial teams, conducting due diligence on deals to facilitate commercial transactions within existing regulations and managing compliance obligations and reporting in the ERCOT Region.
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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.
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The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
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Overview: We are looking for an experienced Regulatory Affairs Manager to manage the entire Product Registration, including being the primary contact with all certification entities, regulatory agencies (including customs), and independent laboratories, including, but not limited to, WQA, NSF, IAPMO, and UL for Culligan Consumer Products Division.
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The Regulatory Affairs Specialist will be responsible for supporting regulatory strategy, conducting regulatory research, producing technical reports to support regulatory implementation or commercialization of new products and processes in the dental/orthodontic area.
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As a staff member of CMC Regulatory Affairs Department of Japan Development Division, a person in charge who is willing to contribute in CMC Regulatory Affairs (RA) tasks from initial stage of new drug development to NDA filing and the approval, addition of dosage form, and change controls.
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The American Heart Association has a phenomenal opportunity for a Regulatory Affairs Manager with our Federal Advocacy Team in our Washington, DC office (home-based work arrangements available.
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QUALIFICATIONSA 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. Demonstrated track record in executing and implementing CMC regulatory strategies for a given molecule.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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Senior Regulatory Affairs Specialist. Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices.
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Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) Regulatory affairs experience in the medical device industry with a track record of successful submissions.
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Job Function Regulatory Affairs. Provide ongoing support to project teams for regulatory issues and questions. Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
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Director, Global Regulatory Affairs CMC-hybrid Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations.
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Responsibilities: The Snr Product Regulatory Specialist is responsible for obtaining registrations and certification approvals for new and existing products, necessary to sell them to worldwide markets.
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You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Gpac
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