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As part of the Regulatory Affairs Asia Pacific (APAC) team, on-site at our Diabetes Care Division HQ location in Alameda, CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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This position reports to the Director, Clinical & Regulatory Affairs. 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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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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As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
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The Director of CMC Regulatory Affairs will oversee and support development CMC team activities for an emerging portfolio of small molecule programs in neuroscience. Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs supports a portfolio of small molecule development programs and marketed products across multiple locations and is committed to providing the best strategy through dedicated teamwork, professional excellence, and collaboration at every opportunity.
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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. You've acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K's, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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The Director of Global Regulatory Affairs CMC is responsible for the development and execution of global Chemistry, Manufacturing, and Control (CMC) regulatory strategies that support the success of products throughout their lifecycle.
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The Director of Energy Policy and Government Affairs will be focused on the development and advancement of a legislative and regulatory policy framework that advances our energy storage, solar, and sustainability solutions offerings.
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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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Build the Regulatory Operations infrastructure and oversee development of standard operating procedures, training materials, and job aids with respect to Regulatory Affairs and Operations.
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The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
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The Sr Director, CMC Regulatory Affairs for biologics is responsible for managing a team of professionals, who work with Gilead's global portfolio of biologics products in CMC Regulatory Affairs.
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If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Director, Regulatory Affairs CMC. 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 / small molecules.
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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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regulatory affairs jobs Title: sr director Company: Meet
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