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As a pivotal leader within the Division of Student Affairs, the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large and multifaceted residential program.
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You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative regulatory strategies for our development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
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Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.
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Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
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Our department works closely with Analytical Development, Operations, Regulatory Affairs, and Quality control to formulate and manufacture innovative ocular formulations. Knowledge of current regulatory guidance and experience in managing IND/IMPD filing.
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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package ( briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions ( with FDA CDRH, EU notified bodies.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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Veeva's Vault Development 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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Communicate effectively with cross-functional teams across the company, including mechanical engineers, software developers, and regulatory affairs, to ensure successful product integration.
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Deep knowledge of Regulatory Affairs, FDA, and EU GMPs, particularly in relation to the development, manufacturing, and distribution of veterinary medicinal products. Collaborate closely with Product Development, Manufacturing Sciences & Technology, Regulatory Affairs, Site Quality (QA and QC), and both Internal and External Manufacturing teams to ensure quality integration.
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Proclinical is seeking a Director, Regulatory Affairs for a mid-sized oncology focused biotechnology company with their site in Massachusetts. Report to our Head of Regulatory Affairs and work side by side with your R&D colleagues to develop and execute innovative regulatory strategies for their development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
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The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
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Stay well informed on policy or programmatic developments affecting municipal governance and service delivery; work with the Director and MAPC’s Government Affairs team to seek legislative, regulatory, and administrative reforms to enhance the effectiveness and efficiency of local government.
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Collaborate with cross-functional teams, such as Regulatory Affairs, Quality Assurance, Medical Affairs, and IT, to address quality and compliance-related issues and drive continuous improvement initiatives.
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The Assistant Vice Chancellor for Academic Administration and Financial Services has primary responsibility in coordination with Administration and Finance, Human Resources and other central offices for the delivery of administrative and financial services to academic affairs units that fully and effectively facilitate attainment of the university’s and individual college’s educational and research goals and objectives.
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regulatory affairs jobs Title: assistant Company: Citi in Boston, MA
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