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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function's Executive Office.
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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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This role collaborates cross-functionally with key cross-functional partners including other GMA functions, Clinical Development/Operations, Regulatory Affairs, Corporate Communications/IR, Legal, Market Access and Commercial, and Research.
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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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2-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regulatory operations. As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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Advanced Degree in science, law, health policy, regulatory affairs or engineering and 8+ years of demonstrated experience in device, pharmaceutical/biologics regulatory, or scientific discipline including at least 3 years of demonstrated experience specifically in regulatory affairs work.
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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. Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Lead the cross functional study team for the EDODM1 Phase 1 study, including clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally.
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Reporting to the Chief of Communications and Public Affairs, the Senior Director of Events will oversee the strategic planning and timely execution of events that reflect our new, community-centric strategic direction and contribute to our vision of advancing a region where access to financial well being is universal and prosperity is shared across race and ethnicity, and provide and special experiences for target audiences and affiliated marketing components.
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Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents.
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As the Director of Regulatory Affairs Operations, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will develop and lead global regulatory operations to support the advancement of multiple clinical trials.
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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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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
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regulatory affairs jobs Title: sr regulatory affairs in Medford, MA
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