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They will be responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) under the supervision of the Regulatory Affairs Manager.
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The Analyst III – Policy & Regulatory Operations is responsible for Local, State, Federal, contractual and accreditation requirements interpretation, gap analysis, project scope development and initiation, resource planning, risk identification and mitigation, and project implementation, as well as timely comprehensive development, review and maintenance of internal and Provider policies, and other regulatory documents.
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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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 Principal Scientist provides regional scientific and regulatory expertise and leverages scientific networks to enable the development and execution of Mars Wrigley (MW) Scientific and Regulatory Affairs (SRA) strategy.
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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Serving as the manager of the Legislative Affairs and Regulatory teams, this Executive will closely coordinate with the Public Policy, External Affairs, Political and State and Local Government Affairs leadership in Washington, Philadelphia, and across the Comcast footprint.
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Minimum of 4 years’ experience working under a quality system or a related discipline (e.g., Regulatory Affairs, Project Management, Quality Systems, R&D, Post Market, Operation Management) Prior experience leading and/or managing others.
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Author product statements and documentation in compliance with international and country specific legislation (e.g. product dossiers, registration certificates) with the support of the SDS authoring specialist for label data, GHS classifications, Dangerous Goods classifications, worker safety or environmental risk assessments and with the support of the Regulatory affairs team for site specifics and environmental regulation.
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Reporting to the SVP, Government Affairs, the VP Government Affairs is responsible for planning, overseeing, and directing the government affairs function for Baylor Scott and White Health (BSWH), which may include federal, state, and local government affairs, policy research, policy advocacy programs, and other regulatory oversight activities that impact BSWH healthcare operations.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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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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I-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance and Bioinformatics. Lead Mechanical Engineer / LME. Lead Mechanical Engineer opportunity to work for a top 10 premier CDMO. This position is working on a recently invested site that will be significantly growing over the next 3 years.
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The Paralegal, Legal Affairs is responsible for providing support to legal operations in different fields of law (e.g. Litigation, Commercial, Labour, Regulatory) across Canada and the United States (U.S.
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Hold a degree in Political Science, Public Administration, International Affairs, Government Relations, Economics, Law, or similar; An Exciting Opportunity at the Nexus of Politics, Energy, Technology, and Sustainability:The Manager of Regulatory Government Relations in Washington, DC USA - Schneider Electric.
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regulatory affairs jobs Title: regulatory project Company: Gpac
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