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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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Position SummaryThis 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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Act as the technical writing expert for CMC regulatory submission documents in cross-functional project teams and as a deputy to the Director, Regulatory Affairs CMC in various internal and external meetings – representing Regulatory CMC as needed.
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Overview The (OEA) at Tufts University School of Medicine is primarily responsible for the medical school academic programs, curriculum design and delivery, system-wide evaluation, faculty development, interaction with the offices of Student Affairs, Registrar, and Professional Degree Programs, and promotion of academic excellence through grant participation for innovative programs.
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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package (e.g. briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions (e.g. with FDA CDRH, EU notified bodies.
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10+ years of relevant regulatory/industry experience in biotech or pharmaceuticals with at least 8 years as the global Regulatory Affairs lead representative on project development teams that have led to marketing authorization.
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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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Works collaboratively with the Graduate Medical Education (GME) Office and Compliance as necessary to ensure the appropriate fiduciary and regulatory responsibility of education and training programs.
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Collaborate with Clinical Development, Regulatory Affairs, and other key departments to promote a robust drug safety culture. Lead and author key pharmacovigilance documents, including medical safety assessments and regulatory responses, applying regulatory guidance for safety surveillance and document authorship.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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Ensure audit-ready-program, GMPs, HACCP, SQF, OSHA and other regulatory requirements are being followed; Completion of sanitation documentation including ATP checks, rack washer temperature checks, sanitation chemical concentration checks, equipment checks, and supply checks; Follow, and ensure all employees follow all SQF practices and applicable regulatory requirements as trained and directed by management.
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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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8+ years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development; both big and small company experience is preferred.
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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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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: consultant in Watertown, MA
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