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Provides advice to clinical development, commercial, and medical affairs senior leaders/teams on broad regulatory aspects of clinical study design, labeling, and submission.
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The Regulatory Affairs Analyst will support and obtain human subjects and safety committee approvals for oncology clinical trials supported by the HDFCCC CRSO. The analyst works independently, under the direction of the Regulatory Affairs Manager, to review cooperative and industry-sponsored protocols, revise local informed consents (ICFs), and submit review packets (protocols, ICFs, and other required documents) to the UCSF IRB and external IRBs.
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Johnson & Johnson is recruiting for a Senior Director, CMC Regulatory Affairs Biologics – New Modalities, located in either Horsham, PA; Titusville, NJ; Raritan, NJ; or Beerse, Belgium. Reporting to the VP CMC Regulatory Affairs (RA) Biologics, the Senior Director, CMC RA Biologics.
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A Juris Doctor (JD) or Master's degree in Regulatory Affairs is preferred. Job Description: We are seeking a highly organized and detail-oriented Regulatory Affairs Manager to join our team.
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The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance.
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Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA.
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CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development. 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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The Senior Director, Regulatory Affairs will drive global Regulatory strategy for the Spur product development portfolio, advancing clinical stage programs in the gene therapy arena.
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Under the supervision of the Regulatory Program Manager of the Regulatory Review Unit, the Assistant Regulatory Affairs Coordinator (ARAC) supports the clinical research efforts of the Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.
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In this role, the Market and Regulatory Affairs Lead will participate as a stakeholder in RTO/ISO stakeholder processes, serve as the liaison for trade groups and collaborate with industry stakeholders to address issues that are relevant to LRE interests throughout the country.
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Work in close collaboration with different functions including preclinical toxicology, preclinical pharmacokinetics, preclinical research, translational medicine, regulatory affairs, biometrics and clinical research.
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Pepsico.com. The Public Policy and Government Affairs (PPGA) team helps PepsiCo navigate the increasingly volatile and complex policy and regulatory landscape in which our company operates.
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The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
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The successful candidate will work collaboratively with the dynamic Federal Legislative Affairs team, as well as regulatory and business teams, to develop policy positions, formulate lobbying strategies, and coordinate Hill outreach to drive desired outcomes on critical issues.
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Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, oncology, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology.
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regulatory affairs jobs Title: clinical supervisor in Fernley, Nevada
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