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Regulatory Affairs Manager (m/f) near to Schaffhausen - Oferta z Jobs.pl

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Regulatory Affairs Manager (m/f) near to Schaffhausen

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  • Regulatory Affairs Manager (m/f) in the metropolitan area of Schaffhausen For our customer who is a leading developer and manufacturer of innovative Products we are looking for a Regulatory Affairs Manger. In this regulatory function located near to Schaffhausen you will perform and support the following activities to ensure regulatory compliance:Your tasks: •Coordination and preparation for new submissions •High intensity of communication and strong collaboration with customers•Development of regulatory strategies and implementation of plans and processes•Coordination and preparation of responses to deficiency letters or authorityrequests•Coordination and preparation of responses of customer requests related to filings and or other regulatory topics•Regulatory assessments •Consulation for Quality Assurance, Production, Quality Control, Sales, Purchasing•Preparation of FDA-GDUFA applications•Support for inspections and audits•Ensure compliance and continued lifecycle management•Network with Global Regulatory groups to coordinate and ensure submission for US as well as other countries •Chemical and Analytical Development Profile•Bachelor's degree with a minimum of 6+ years of relevant experience •Regulatory CMC or CMC experience would be a plus•Basic knowledge of regulatory requirements is required •Drug development experience is a plus•A working knowledge of global HA laws, regulations, and guidance is required•Solid understanding of chemistry relevant is a plus•A demonstrated ability to communicate regulatory requirements is essential•Cross-functional communication as well as cross-company •Good knowledge of EnglishAre you motivated, committed and flexible? Are you offering a multifaceted challenge in a dynamic international company with fair terms and an outstanding infrastructure? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress? Then please send your complete application documents by email to Petra Ognjenovic: case of any further question, please do not hesitate to contact Petra Ognjenovic: .Lawrence Harvey is acting as an employment agency in regards to this position.Visit our website and follow us on Twitter for all live


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