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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Specific responsibilities include Quality Systems, FSMA, HACCP, GFSI/BRC, regulatory audits, food safety training, Regulatory Affairs, Plant Quality Assurance, Vendor Compliance, and Consumer Affairs.
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Evaluate and advise senior management, the VP, Legal Affairs & Deputy General Counsel and the Chief Legal Officer on regulatory and privacy legal issues relating to Company products/services in conceptual or development phases to include data usage rights, as well as on appropriate legal courses of action to meet strategic Company goals for product deployment, revenue, and strategic initiatives.
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Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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SummaryThe Regulatory Affairs Specialist will reside within strategic business unit, Huber Specialty Minerals (HSM), at Huber Engineered Materials (HEM). Serve as primary contact for HSM hazard communication support and collaborate with HEM regulatory affairs for SDS/Labeling support.
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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The Federal Regulatory Affairs Manager will collaborate closely with the North America Team Leader and business-lead Vice Presidents to develop regulatory strategies to ensure registrations are obtained and maintained to meet business objectives and timelines.
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Partners with Sr. Privacy Counsel, Cyber Security, IT, Regulatory Affairs and Enterprise Risk Management to help manage privacy risk exposure. Partners with Sr. Privacy Counsel, Cyber Security, IT, Regulatory Affairs and Enterprise Risk Management to help manage privacy risk exposure.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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This individual will work collaboratively with members of all departments within the company, including but not limited to Offshore Wind Development, Onshore Development, Origination, Transmission, Regulatory, and Environmental Compliance & Strategy.
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High comfort providing healthcare regulatory advice (Anti-kickback law, FDA, government affairs, antitrust). Ability to work closely with, facilitate interactions within, and influence large cross-functional teams (including representatives from other areas of the law department, regulatory and compliance professionals, and Oncology Ecosystem colleagues.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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A minimum of 6-10 years experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. The ideal candidate will have experience in chemical and environmental regulatory compliance, packaging regulations, product stewardship and industrial risk management in the medical device or manufacturing industries.
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The Director of Regulatory Affairs and Customer Compliance is responsible for overseeing and providing leadership for all regulatory and export compliance matters within the MFI Integrated Supply Chain.
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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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regulatory affairs jobs Title: intern Company: Microvention
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