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The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
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Knowledge and experience in clinical and CMC regulatory affairs for pre-licensed and clinical RA for licensed biologic product or vaccine. As a Director, Regulatory Affairs, Vaccines you will e nsure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.
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The Regulatory Affairs Director (RAD), Oncology Cell and Gene Therapy provides strategic regulatory leadership to influence the development of our innovative products across all stages of development.
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Five or more years of experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence. A solid experience in procedural/ registration US regulatory affairs (including as US authorised agent - liaison with US FDA.
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The Archaeology Program Manager will have extensive knowledge of archaeology data collection methods, data analysis, and data interpretation, demonstrated knowledge of the regulatory environment, high-level technical writing skills, and the ability to direct and mentor staff.
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Analytical Development, Vaccine Development, GMP, quality control, compliance, investigation and analysis, method validation, method transfer, regulatory filing, Large Molecule, analytical method, regulatory standard, glp, validation protocol, analytical methods, release, stability, in-process assays, technical liaison, deviations, investigations, drug development, ICH, CMC guidance documents.
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Basic Qualifications:Bachelor's DegreeExperience of all phases of the drug development process in Regulatory Affairs preferredKnowledge of clinical trial and licensing requirements in all major countries (EU,US, JP, China) and ideally knowledge of other key Agency processes globally.
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Maintain and update files of all applicable regulatory documentation for IACUC or IRB (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.
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Ability to collaborate with and influence other functional areas such as Manufacturing, Validation and Regulatory Affairs. Provide scientific guidance and oversight while factoring in technical, regulatory, and intellectual property considerations and risk assessment.
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Multidisciplinary grasp of public affairs, including government affairs, policy, advocacy, PR and issues management, and their associated synergies. Minimum 5 years of Hill or other commensurate government affairs experience.
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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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This position interfaces with key divisional and cross-functional teams, including Expert Committee Management (ECM), Legal, Global External Affairs, QA, IT, HR, Equity, Travel, Finance, and USP’s Expert Volunteers community, to optimize efficiency within Volunteer Engagement & Compendial Operations while maintaining compliance with USP policies.
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15 years of experience in drinking water treatment with at least 5 years in water quality and treatment (water quality analysis, treatment evaluations, process design, regulatory compliance assessments, distribution water quality analysis, etc.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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They possess deep expertise in designing and interpreting real-world evidence studies using advanced statistical methods and various data sources, coupled with a thorough understanding of regulatory guidelines.
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regulatory affairs jobs Title: regulatory affairs manager Company: Aerotek in Germantown, MD
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