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Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
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The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes' European office.
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Under the direction of the Senior Director, this position collaborates and regularly meets with key stakeholders, including Clinical Research Disease Center Managers, CTO Associate Directors of Regulatory Operations, Regulatory Affairs, Network and Satellite Program, Project Management / Monitoring and Education and Training to promote excellence and streamlined collaboration in clinical research across all disease groups.
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The Legislative Affairs co-op will report directly to the Chief of Intergovernmental Affairs, and work as part of the Legislative Affairs Team to support their ongoing projects. Learn day to day activities of a Legislative Affairs/Intergovernmental operations.
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POSITION SUMMARY: Under the direction and guidance of the Associate Vice President, Career and Digital Strategy, the Senior Director of Industry and Employer Engagement will develop and lead the implementation of a comprehensive strategic plan that drives engagement with industry, including employers, recruiters and alumni in coordination with Academic Affairs, the International Career Center (ICC) and Alumni Affairs.
Starting at $250Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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We are seeking an excellent individual for a Principal Scientist position within the DMPK group to support regulatory bioanalytical work. The successful candidate will have a strong experimental background with an established track record of hands on regulatory bioanalytical assay support and technical problem solving.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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We are looking for a Director of Regulatory Reporting, a leadership position within the team that is responsible for ensuring the overall integrity of trade and position reporting submitted to the regulators for the Fidelity Broker-Dealers, National Financial and Fidelity Brokerage Services, as well as for correspondent client broker-dealer firms.
$85,000 - $144,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Expert in GCDMP, CDISC standards, regulatory compliance (21 CFR Part 11, GDPR), and proficient in MedDRA and WHO-Drug coding, ensuring adherence to ICH GCP and industry standards. Bachelor’s Degree in Life sciences, including a min of 8 years in CDM, leading critical oncology or immunology projects from startup to database lock, adept at handling data for regulatory submissions, and proficient in Veeva EDC system management with a solid scientific educational background.
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This position reports directly to the GVP Global Medical Affairs and will be evaluating, refining, updating, and growing the Drug Safety & Pharmacovigilance function at Kiniksa. Provide strategic consultation, guidance and oversight for safety sections of all regulatory documents, including but not limited to NDA/BLA/MAA, EU Risk Management Plans/REMS, PSUR/PBRERs, DSURs, ICFs, public presentations and key scientific articles and abstracts.
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Executing model risk management activities and projects consistent with the Enterprise MRM framework, industry best-practice and regulatory guidance. The incumbent is responsible for executing model risk management activities consistent with the framework, industry best-practice and regulatory guidance.
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The impact you will make:Agios Pharmaceuticals is searching for a dynamic Senior Manager, Medical Writing to join our growing Regulatory Affairs & Medical Writing team. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
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The person will work directly with stakeholders across – ESG Investments, ESG Product Strategy, ESG Data and Operations, Client, Product and Regulatory Reporting, and Enterprise Risk Management to understand their data and reporting requirements and to translate requirements into functional specifications for technology partners building/ enhancing IT solutions for ESG reporting.
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Lead and synchronize a cross-functional team, including R&D, regulatory affairs, CMC, commercial, and finance to align with program objectives. Comprehensive understanding of the entire drug development process, including in-depth knowledge of regulatory environments, clinical development, Chemistry, Manufacturing, and Controls (CMC), and strategic approaches to commercialization.
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regulatory affairs jobs Title: principal consultant in Waltham, MA
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