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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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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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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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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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Use project management techniques to identify, develop, and maintain planning tools (e.g. spreadsheets, MS Project, MS Teams, Smartsheets) in support of CMC regulatory/ product development projects.
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This position is PHMSA's Supervisory Attorney-Advisor for Regulatory Affairs Law/Office of Chief Counsel, with comprehensive responsibility for the direct supervision of staff as the Deputy Assistant Chief Counsel for Regulatory Affairs.
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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 VP, HR R&D and Regulatory/Clinical Affairs will have a team of Director and HR Business Partners reporting into the role, and will also act as a coach and mentor across the organization for HRBPs∯*∯ The VP, Human Resources must collaborate with the Centers of Excellence in alignment with global HR leadership to ensure proper alignment of talent, compensation and operational effectiveness.
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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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Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable.
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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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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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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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Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs. The Clinical Affairs Director for Beckman Coulter Diagnostics is responsible for leading comprehensive global clinical trial strategies to support the complex Clinical Chemistry and Immunoassay Biomarker-Flywheel (Biomarker) program and for managing a multi-level team of clinical managers and clinical scientists/affairs associates.
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regulatory affairs jobs Title: intern Company: Alcorn State University
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