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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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Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC.
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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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The Director will chair the respective neurology TA Global Publications Team as well as engage with cross-functional partners including but not limited to research, clinical development, marketing, market access, medical affairs, regulatory affairs and biostats.
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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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This position is hybrid, based in Santa Monica, CA, and reports to the Executive Director, CMC Regulatory Affairs. The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies.
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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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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Collaborate with regulatory affairs to support regulatory submissions and inspections.
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Collaborate and enhance partnerships with all departments to obtain optimal GPvP and PDMA education, training, compliance, and inspection readiness (i.e. Pre-Clinical, Clinical Development, Drug Safety, Medical Affairs, Regulatory Affairs and Commercial Operations.
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Proclinical is seeking a Director, Regulatory Affairs for a mid-sized oncology focused biotechnology company with their site in Massachusetts. Director, Regulatory Affairs - Permanent - Boston, MA.
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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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Syndax has an exciting new opportunity for an Associate Director, Regulatory Affairs. Syndax Pharmaceuticals is looking for an Associate Director, Regulatory Affairs.
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Must possess a thorough understanding of the FDA, OIG, HIPPA, PhRMA, GCP and other international regulatory/ethical guidelines relevant to the pharmaceutical industry & clinical trial conduct, and to ensure compliance with these external as well as internal Eisai guidelines and standard operating procedures.
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The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products.
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The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned programs in alignment with the corporate goals.
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regulatory affairs jobs Title: director in Boston, MA
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