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A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapySelf-organizer, meticulous hands-on habits, keen attention to detail.
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Assist in the preparation and review of bioanalytical data and reports suitable for regulatory submission. Background in molecular biology techniques such as cloning, site-directed mutagenesis, DNA and RNA isolation and purification, sequencing, RT-PCR, and qPCR.
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Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development.
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Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CRO's/CDMO's. The candidate will work with Chief Technology Officer to lead authoring the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met.
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Experience in the financial industry demonstrating knowledge of regulatory reporting and analytical skills is preferred. FINRA is a registered trademark of the Financial Industry Regulatory Authority, Inc.
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Collaborate closely with and provide direction to cross-functional partners (e.g. Customer & Disease Strategy, Insights & Analytics, Market Access, Medical, Sales, Training, Corporate Affairs) for the development and implementation of both strategic and operational plans.
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Assists the Director in special projects and other regulatory compliance-related initiatives. We have an exciting opportunity for a Principal Analyst, MRTS Regulatory Compliance: The Principal Analyst in MRTS Regulatory Compliance is responsible for a wide range of tasks in support of various regulatory compliance functions for Market Regulation and Transparency Services (MRTS), including those related to responding to government access and data requests, coordinating former employee reviews, and administering department-wide policies and procedures.
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Write and review standard operating procedures for cell line development processes and instrumentation under the direction of the FTL. Maintain complete documentation records, including a detailed and up-to-date laboratory notebook, to support regulatory filings.
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Oversee the related expansion and optimization of global capabilities across manufacturing, quality, process development, analytical development, supply chain, and regulatory affairs. Collaborate closely with the Chief Operating Officer and their leadership team to effectively manage operations concerning the Novavax COVID vaccine, the company's proprietary MATRIX adjuvant product, and the global launch of new COVID variant vaccines, alongside innovative products like the Flu-COVID Combination vaccine (CIC.
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The Biologics Virus Clearance Validation Leader is responsible for cell culture and purification process stretching studies, resin lifetime studies, buffer/solution hold time studies, at-scale membrane and resin lifetime verification studies, virus clearance studies, limit of in-vitro cell age studies, preparation for the regulatory files, PAI and support through the product lifecycle including knowledge management.
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Position Description: The Bioanalytical Quality Assurance Specialist plays a crucial role in ensuring compliance with regulatory standards and quality procedures within our organization. Provide support for Regulatory and client inspections.
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The General Counsel is the head of the Legal Department and is responsible for the legal affairs of the entire company. Knowledge of legal and regulatory requirements related to government and commercial contract negotiation, including but not limited to the FAR, DFAR, and other US government procurement regulations.
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As a Preschool Assistant Teacher, you will be responsible for assisting in the implementation of a superior Early Childhood Education curriculum while maintaining a happy, safe, and healthy education environment for the children.
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As a Public Affairs Specialist, you will manage digital content, and provide plain language and editorial expertise for HRSA.gov. You will represent HRSA, as appropriate, in collaborative Internet and Intranet communication activities and enhance online information dissemination through social medial and other digital platforms.
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4+ years of experience in regulatory affairs, product development, research & development, clinical research. This is an exciting opportunity to join GMED NA and work as a Certification Project Manager with Experts, Product Reviewer, Internal Clinician, and Auditor.
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regulatory affairs jobs Title: regulatory affairs assistant Company: Jobget in Gaithersburg, MD
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