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Ensures all appropriate strategic CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
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I have a talented group of recruiters who specifically source Technical Sales Professionals, Scientists, Regulatory Affairs, Scientific Affairs, Executive Technical professionals, Quality Assurance, Product Development, Technical Service, Nutrition, Analytical and Corporate Chefs.
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The Product Safety Toxicologist will report directly to the Regulatory Affairs Director. We are seeking an experienced regulatory toxicologist as a Product Safety Toxicologist for our global Regulatory Affairs organization.
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Internally, the role collaborates closely with other members of the Scientific Affairs teams as well as product marketing, development, and field representatives. ATEC’s Scientific Affairs team is responsible for regulatory, testing, and research activities in support of the company’s initiatives.
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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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Prepares clinical study documents and coordinates with additional collaborators including product management, statistician, regulatory affairs, clinical research management, and contract research organizations (CROs.
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As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U.S. and other regions (Asia/Pacific, Latin America, Africa, Europe, and Canada.
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The role will be responsible for influencing senior internal partners in Research, Bioprocess Development and Regulatory Affairs and lead external academic collaborations and contract manufacturers to deliver novel vaccines.
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A critical component of the export control program is to work collaboratively with the Vice Provost for International Affairs; Office of Technology Licensing, Environmental Health & Safety, Office of the General Counsel, and the Office of Finance & Treasury.
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5-7 years of experience in food product development, preferably confectionery. This position supports and manages product development activities and projects from concept through commercialization, including, but not limited to trend monitoring, concept development, raw materials sourcing, benchtop development, raw materials sourcing, benchtop development, designing and managing trials and start-ups, writing technical reports and documenting procedures.
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The candidate will work closely with Regulatory Affairs, Regulatory CMC, Quality, Global Patient Safety, Program Strategy Teams (PSTs), Development Teams, Clinical, and global affiliates.
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The Senior Director, Regulatory Affairs CMC is responsible to manage and help develop regulatory strategies to support development of innovative products, as well as to ensure efficient management of approved and marketed products.
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The Senior Director, Commercialization and Development Counsel will be responsible for providing legal counsel and business advice to Commercial, Clinical, Medical and Pharmacovigilance leadership and the Marketing, Market Access, Regulatory Affairs, Medical Affairs and Drug Safety teams on relevant areas of law, policy, business opportunity, risk, and mitigation strategies.
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Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle.
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Use project management techniques to identify, develop, and maintain planning tools (e.g. spreadsheets, MS Project, MS Teams, Smartsheets) in support of CMC regulatory/ product development projects.
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