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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
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In conjunction with members of the team, develop high quality clinical, commercialization and LCM submissions, using proactive regulatory CMC strategies and submit them as planned. Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.
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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. As a Regulatory Affairs Manager, you will interact with internal and external customers, including state/provincial and federal regulatory authorities, in support of Nova Source products.
$7,500 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice. We are looking for someone who already has an interest and established foundation in regulatory affairs and human subjects research, and/or specialized knowledge of working with cellular therapies.
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Provide legal advice and support for our U.S. businesses and Environmental, Health, & Safety team covering a broad range of environmental, safety, and regulatory issues. 5 to 15 years practicing law with experience in environmental or regulatory work (5 years of law firm/private practice experience preferred.
$190,000 - $240,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Engages with cross-functional team members in Clinical Affairs, Operations Center of Excellence, Professional Affairs, Health Economics and Market Access, R&D, Regulatory, and Medical Safety and Infection Prevention & Control to review clinical evidence and to evaluate a product’s risk-benefit calculus.
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Alexion, AstraZeneca Rare Disease is seeking a highly motivated co-op with educational experience in Regulatory Affairs. This co-op student will be a member of and support regulatory subteam activities and work on a variety of projects across Regulatory Affairs (RA) including Development Strategy, Established Products, Labeling, Operations, CMC, Advertising & Promotion, and Clinical Trial Excellence.
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Director, CMC Regulatory Affairs. 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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Supports the Director, Regulatory Law, Government Affairs and Trade Compliance in managing risk within the defined scope of responsibility. Reports to: Director, Regulatory Law, Government Affairs and Trade Compliance.
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Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas. The Medical Director provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area.
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Resolve complex, escalated compliance issues within Quality Assurance and Preclinical/Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data management and Pharmacovigilance.
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Currently, PreScouter is actively recruiting full-time scientific consultants / project managers with experience in the following, and related, domains: Food Science and Technology, Process Engineering, Clinical Nutrition and Dietetics, Biochemistry, Consumer Psychology and Market Research, Supply Chain Management and Logistics, Regulatory Affairs and Food Law, Biotechnology and Fermentation Science, Chemical Engineering, and related disciplines.
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The Army public affairs specialist participates in and assists with the supervision and administration of Army public affairs programs primarily through news releases, newspaper articles, Web-based material and photographs for use in military and civilian news media.
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regulatory affairs jobs Title: sr director Company: Gsk
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