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Regulatory Affairs Senior CMC Manager - The Netherlands - Strategic EM Nr ref.: /JOBS.pl Regulatory Affairs Senior CMC Manager - The Netherlands Location: The Netherlands close to Amsterdam and the Hague My client is a top ten highly rated and extremely successful Biopharmaceutical company with a Global reach and they are seeking a Regulatory Affairs CMC senior Manager for a role covering CMC regulatory strategies for assigned projects which cover EMEA markets. This is a dynamic, international and pharmaceutical client company that has created a culture that nurtures autonomy and creative thinking and provides opportunities for individuals to excel in a collaborative, team-based environment. Their entrepreneurial mindset fosters diverse perspectives and drives their passion for impact. Role: You will be focused on bringing technical expertise, creativity and innovation as you maximize the business benefits balanced with regulatory compliance. Coordinate and drive global regulatory strategy for complex submissions and determine and drive the execution of regional CMC regulatory plans in line with the global regulatory strategy. Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in Regulatory CMC, Drug Regulatory Affairs (DRA). Initiate and lead regional Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals. Provide leadership within the department through specialised matrix functions and by utilizing CMC regulatory expertise to drive improvements. Represent Regulatory CMC at Global Supply Support Teams. Experience needed: 5-10 years in Regulatory Affairs Knowledge of EU MAA's & CMC dossier build Knowledge of HA negotiation Project/portfolio management experience Strong leadership, negotiation and communication skills Package: Salary up 90,000 + bonus Extensive healthcare package Relocation available if needed ______________________________________________________________________________________________ If you wish to apply for this role, please send your CV with a covering note to or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on (0). ______________________________________________________________________________________________ About Advanced Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs. We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at . We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter. Keywords / Key words: Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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