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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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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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The (Senior) Director, Business Planning & Operations, is responsible for managing business processes in the Alexion Regulatory Affairs team and is a member of the Alexion Regulatory Affairs Leadership Team (RALT.
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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. Join Takeda as a Senior Director, GRA Pharmaceuticals 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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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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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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The candidate who assumes this role will lead a team of compliance professionals supporting execution of the Bank compliance management program, including risk assessments, compliance policies and procedures, training, issues management, complaint administration, regulatory filings, third party risk management and the Community Reinvestment Act (CRA.
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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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The Director, AML Modeling will oversee a team of quantitative professionals by providing strategic and thought leadership to protect the bank from regulatory and reputational risk. Executing model risk management activities and projects consistent with the Enterprise MRM framework, industry best-practice and regulatory guidance.
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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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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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regulatory affairs jobs Title: director clinical lead in Cambridge, MA
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