... expert and thought leader for Regulatory Affairs in Europe (western and eastern). It covers regulatory affairs for all phases from drug development: pre-clin, clinical, submission ...
... Lead a team of country regulatory managers and associates responsible for the ... of experience in registration and regulatory affairs of plant protection or biological control products. Regulatory experience in the DACH market ...
... minimum of 7 years progressive regulatory affairs experience in pharmaceutical or biotechnology industry or with regulatory agencies, including knowledge & experience applying drug or device laws & regulations for ...
... responses to queries raised by regulatory agencies and follow up on these requests. Provide support to the Regulatory Affairs Managers in the hubs in topics ... stakeholders and support to the Regulatory Affairs Managers in the hubs in topics ...
... affairs within the pharmaceutical, biotechnology, or CRO industry, with a focus on clinical development. CRO experience is essential. In-depth knowledge of European regulatory requirements and guidelines governing clinical trials and drug development ...
... diploma or Master Degree in Regulatory Affairs or further pharmaceutical specialization (e. ... Organizations or in a regulatory authority with at least 10 year experience in regulatory affairs with an emphasis on regulatory pre-submission and post-approval ...
... a talented Regulatory Affairs Manager to lead their growing Pharmaceutical Regulatory team of 5 associates. In ... review regulatory submissions, including new drug applications, variations, renewals, and responses to regulatory queries. Serve as the primary ...
... Regulatory Affairs, CHC Science Hub Regions countries, CHC Global Public Affairs; GRA Science & Policy; CHC Science ... regulatory experience desirableIn depth understanding of the prescription and non-prescription drugs, herbal medicines, vitamins and mineral ...
... with stakeholders.- Develop Regulatory Affairs processes and procedures for the Global Regulatory Affairs organization.- Evaluate TSPDx Regulatory Science Team resource needs and ... years of experience in regulatory affairs, including a minimum of 5 ...
... or More Years of relevant drug CDx co-development experience including experience within Regulatory Affairs, specifically regulatory expertise on related IVDR requirements ...