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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans. Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC.
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You will guide the business with respect to quality and regulatory affairs issues, complaint handling and initiatives to maximize the operational capacity of Oticon Medical's distribution of auditory implantable devices.
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CMC Regulatory Affairs Manager (Remote) CMC Regulatory Affairs. Regulatory Affairs Manager. This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
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Reporting to the Senior Director of Regulatory Operations, you will be responsible for assembling, formatting, and publishing regulatory dossiers (e.g., IND, CTA, BLA, MAA) for global registration and lifecycle management submissions (e.g., supplements, amendments, variations) to meet corporate objectives for both ongoing business and new product development.
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In this role, you will work closely with cross functional teams in Biologics Analytical Research and Development GMP laboratories, Biologics Process Research and Development, Global Quality and Regulatory Affairs-CMC, and our partners in in the commercial/manufacturing to support commercialization of our company's large molecule products.
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Charter cross functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations. Oversee product technical lifecycle management with regards to process control strategy (post-approval) process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registration detail.
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8+ years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development; both big and small company experience is preferred.
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5) Charter cross-functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations. 12) Oversee product technical lifecycle management with regards to process control strategy process/yield improvement, process knowledge management, batch deviations, and ensure accuracy of regulatory CMC registration detail.
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This Sr Director will operate across many corporate functions including Global Patient Safety (GPS), Global Regulatory Affairs (GRA), Clinical Design, Delivery and Analytics (CDDA), Manufacturing, MQO, Global Quality Assurance Auditing & Compliance, Legal, and Ethics and Compliance; and third-party organizations (TPOs.
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Reporting to the Head of Regulatory Affairs & Quality, the Regulatory Affairs Specialist will support global pre and post market matters including regulatory submissions, medical device software design reviews, product releases, deviation management and change control activities, product promotional activities, labeling review activities, product registration and listing databases, global product registrations requests, and post market actions.
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The Registration & Regulatory Affairs Manager (R&RA Manager) for FMC Global Specialty Solutions (GSS) is accountable for leading the regulatory function in developing and implementing regulatory strategies and tactical plans to grow and defend the GSS product portfolio.
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The (Temp) Regulatory Affairs Associate – EU MDR Technical Documentation reports to the Regulatory Affairs Director and will work with the Iridex Team (including both Regulatory and Cross-functional colleagues) and consultants to obtain, prepare, and provide information in support of EU MDR submission.
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Understand and recommend strategies based on current local registration requirements and applicable industry standards Supports the professional development of regulatory staff through mentorship and guidance Present to upper management at required intervals and effectively communicate successes and challengesMust maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.
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