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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.
$113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.Demonstrated organizational leadership skills at both functional and enterprise levels.
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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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We are now looking for a Regulatory Data Office (RDO) Analytics and Reporting Senior Developer to join us in Global Regulatory Operations (GRO) within Regulatory Affairs. The jobholder will be a member of the RDO Analytics and Reporting group, which is specifically tasked with providing analytical and reporting services in support of the Regulatory Affairs business.
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We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
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In this newly created role, the Senior Manager, Public Policy, EMEA – EU and Regulatory Affairs will be responsible for developing, implementing, and reporting on the company’s public affairs program at the European Union (EU) level and on regulatory topics that impact the business across major markets (e.g. transpositions of EU directives across member states.
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Policy Advocacy: Monitor regulatory developments and policy initiatives, coordinate with the Regulatory Affairs Specialist, represent the company's interests through proactive engagement, and assist with analysis and drafting papers.
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Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
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Act as a liaison between the preclinical research team and other departments such as clinical development, regulatory affairs, and quality assurance. As a Preclinical Study Director, you will oversee the planning, execution, and reporting of preclinical studies in compliance with regulatory standards (e.g., GLP.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
$315,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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This Regulatory Affairs Manager – Digital Health Technology will work on-site at our Alameda, CA location in the Diabetes Care Division. This Regulatory Affairs Manager – Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment.
$218,500 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago
regulatory affairs jobs Title: intern Company: Catalina Marketing
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