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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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Collaborate Cross-Functionally: Work collaboratively with internal and external stakeholders, including regulatory affairs, clinical research, quality assurance, and IT teams, to achieve project objectives and deliver high-quality solutions that meet business needs and regulatory requirements.
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The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements.
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The Regulatory Affairs Specialist will provide regulatory support for the Catalent Cell and Gene Therapy sites. This position will evaluate facility change controls for compliance with applicable change control guidance and will maintain site master files and Type V DMFs. In addition, the Regulatory Affairs Specialist will provide audit support and assist in preparing for group meetings and communications as appropriate.
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Work closely with cross-functional teams, including R&D, quality, manufacturing, and regulatory affairs, to ensure seamless product configuration management. The successful candidate will collaborate closely with engineering, regulatory, quality, cost accounting and manufacturing teams to ensure that product configurations meet customer needs and regulatory requirements.
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7+ years of experience in quality assurance, regulatory affairs, or related roles within the pharmaceutical manufacturing industry. Collaborate with quality control, production, and regulatory affairs teams to assess the impact of deviations on product quality and safety.
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The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements.
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The Federal Regulatory Affairs Manager is responsible for oversight, planning, and management of registration submissions with a focus on US Federal product registrations. The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products.
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Certis Biologicals is currently seeking a highly motivated individual to join the Regulatory Affairs team as a Federal Regulatory Affairs Manager. The Regulatory Affairs team secures product approvals in the United States (including the individual States and territories), other NAFTA countries (Canada and Mexico), as well as the rest of the world (Europe, Africa, Middle East, Asia, and Latin America.
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