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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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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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Guides and ensures that the clinical study documentation (documents, images, and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
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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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This position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Expertise in commercial healthcare and FDA regulatory law, specifically related to market access, pricing and price reporting, patient support, government contracting matters, and other laws and regulations related to the development and commercialization of pharmaceutical products.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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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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Certified Regulatory Compliance Manager (CRCM) or equivalent certification (preferred)The base pay range represents the anticipated low and high end of the pay range for this position. About the Role:We are seeking a highly experienced and skilled Regulatory Compliance Manager 3.
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The Assistant Director for Policy and Public Affairs will play an important role in advancing AJC New England’s strategic interests. The Assistant Director for Policy and Public Affairs does all of this while adhering to AJC’s core values: Respect, Teamwork, Integrity, Excellence, and Accountability.
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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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Veeva’s VaultDevelopment Cloud helps organizations eliminate silos and transforms business processes across clinical, regulatory, quality, and drug safety with greater efficiency and compliance.
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This position reports to the Executive Director of MSLs. The MSL will have contact with internal colleagues in compliance, regulatory, pharmacovigilance, marketing, sales, research and development, medical science, medical information, market access, training, strategy and portfolio management, and HOVA. This internal collaboration is considered a fundamental and essential part of the position.
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As an integral member of the team that will be tasked with product development, the Associate Director Regulatory Affairs will also serve as a subject matter expert (SME) for assigned development programs, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.
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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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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Chelsea, MA
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