Proclinical have partnered with a global pharmaceutical company to find a talented Senior Regulatory Consultant who is an expert in vaccine products. This Zurich based role is initially for 12 months with the opportunity to extend.
Oversight of Regulatory activities (including registration, lifecycle & development) Support submissions for vaccine products across Europe (dossier / MAA) Operation support across all aspects of drug development and approval Oversight of clinical trials in Europe Collaboration with other regions on strategy for projects Participate in the selection and justification of Registered Starting Materials (RSM) and their characterization. Identification of associated quality and regulatory risks Management of risk analyses of elemental impurities and nitrosamines
Skills and Requirements
Good knowledge of regulatory procedures (EU/ France) Knowledge in CMC Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel Experience in CMC writing (Variation package) will be appreciated Knowledge of the usual analytical methods (LC-UV, LC- MS, GC-FID, etc...) and ICH standards. Fluent in English and French and another European language for daily contacts with local and international partners
In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.