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... for the development of the CMC regulatory strategy for submissions. These submissions ... IND/CTA, NDA, CTD and MAA regulatory filings. Collaborate with other relevant ... functions to prepare and..
... Therapeutic Area Head Support the Regulatory Affairs Therapeutic Area Head for IN&F ... leading and developing the global regulatory strategies, overseeing health authority interactions ... hiring, retention, and development..
... a difference. Position: Executive Director, Regulatory Affairs Team Leader Supervisor: Vice President, ... Team Leader Supervisor: Vice President, Regulatory Affairs Department: Global Regulatory Affairs Prerequisites Bachelors in scientific discipline...
Senior Director, Regulatory Affairs n nThis position is responsible ... overseeing, supervising, and managing the Regulatory Affairs (RA) function. This includes Regulatory CMC, Regulatory Program Management, Regulatory Submissions, Regulatory Information,..
... highly motivated, self-driven and enthusiastic CMC professional seeking an opportunity to ... advance your career in the regulatory sciences? If so, this CMC Regulatory Affairs Project Manager could be..
... will Achieve More with Intellia:The Manager, Clinical Operations is an integral ... Data Management and Biostatistics, Medical, Regulatory Affairs, Clinical Pharmacology, Clinical Supply and ... Clinical Pharmacology, Clinical Supply..
Regulatory CMC Biologics Manager The GCMC manager possesses CMC regulatory knowledge and quality expertise to ... quality expertise to independently prepare regulatory assessments & contribute to global ... assessments &..
... the U.S. Department of Veterans Affairs, the U.S. Department of Defense, ... to Doing Businessn Job DescriptionnOur Regulatory Affairs team brings essential generic quality ... the United States by..
Business Title: Director Regulatory Affairs Strategy Requisition Number: 95285 - ... is currently seeking a Director Regulatory Affairs Strategy in Customer & Operations ... Sciences clients, primarily to the Regulatory..
... DESCRIPTIONAs a Senior/Executive Director in Regulatory Affairs, CMC, focusing on diagnostics and medical ... responsible for establishing the overall regulatory strategy for contemporaneous development of ... will serve to..
... This role will handle all regulatory submissions related to Xtandi capsules ... strategic planning and execution of regulatory activities for development, registration and ... the generation and completion of..
... who will be accountable for CMC product strategy to enable advancement ... include leading or managing the CMC PST, representing CMC at Vir Program Team meetings, ... alliance partnerships..
Associate Manager, Regulatory Publishing (BASKING RIDGE, NJ)Regeneron Pharmaceuticals, ... Inc. is seeking an Associate Manager, Regulatory Publishing (Basking Ridge, NJ) to ... documents. Manage the building of Regulatory submission deliverables..
... lives. For an assigned product,The CMC submission managers support and may ... parts of the development of CMC strategy and plans; the planning, ... planning, preparation, and submission of..
... global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing ... the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for ... and..
... Summary:rnrnThe Director and Head of CMC Regulatory Affairs leads the successful operation of ... the successful operation of the Regulatory Affairs (RA) business functions at Theragent ... consult on..
... for the development of the CMC regulatory strategy for submissions. These submissions ... IND/CTA/BLA, NDA, CTD and MAA regulatory filings. Support project teams (e.g. ... and line extensions. Interact..
... mastery of the fundamentals of regulatory affairs, the Associate Director will have ... the Executive Director, Head of Regulatory Affairs, The Associate Director establishes regulatory presence and is a..
... Ahead Together. Job Title RA CMC Development, Senior Manager In this role you will... ... role you will... Drives the CMC strategy, coordinates thetimelypreparation and authors, ... and authors,..
... is essential and the ever-changing regulatory environment requires forward thinking and ... implement chemistry, manufacturing and control (CMC) regulatory strategies for small and large ... and devices to meet..
