DRA Affairs Global Strategy Lead EU Nr ref.: /JOBS.pl DRA Affairs Global Strategy Lead EU - Basel, Switzerland - Salary based on experience, very competitiveIf you would like to apply for the position or wish to learn more about the role and company please call Daniel on 0044 (0) or email your CV with a brief covering note to medium sized global biopharmaceutical company is currently seeking a senior team member to join their global Regulatory Affairs team. This position has arisen due to a departmental restructure which will enable effective coverage of regulatory responsibility allowing for more specialist and effective coverage of products and Regions. Primary responsibilities will include developing Regulatory strategies globally and interacting with health authorities. This will be focused on both developmental and post marketed products.You will be based at a state of the art (European headquarters) site in Basel, Switzerland. We are looking for established Regulatory Strategy, Project Managers with experience which includes biologics and small molecules working with clinical regulatory responsibility (ph. I - III). You must have European experience working with New chemical entities.You will be providing technical knowledge and support of clinical trials applications, regulatory requirements for study start up and clinical trials applications. This will require experience working with Regulatory Strategy and Regulatory intelligence. There will also be a requirement to be working with post marketed regulatory responsibilities (MAAs etc.)-Strong Project Management focus across Global Projects (EMEA, ROW)-Experience with being the point of contact with Regulatory Agencies-Experience with EU submissions-Exposure to the full life cycle of product development-Specific experience working within clinical development (ph. I - III) and post marketing-Strong communicator in English (essential), French and German (favoured)If you would like to apply for the position or wish to learn more about the role and company please call Daniel on 0044 (0) or email your CV with a brief covering note to am able to speak to you and share information regarding many Reg Affairs opportunities currently available and future vacancies.SEC are a Recruitment and Employment Confederation member and ISO9001:2000 accredited specialist recruitment organisation working within the Pharmaceutical, Biotech and CRO industries. If you are interested to learn more about further opportunities in the UK and mainland Europe, please contact Mark on 0044 (0) 20 7 for a confidential discussion.SEC Recruitment Limited is acting as an Employment Agency and or an Employment Business Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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