Regulatory Affairs Manager
A popular biotechnological company are looking for Regulatory Affairs Manager to join their team working remotely from their location. This is a unique opportunity to join a company that can transform the face of medicine.
- Regulatory compliance
- Scientific support for the preparation of regulatory dossiers
- Participate in the selection and justification of Registered Starting Materials (RSM) and their characterization.
- Evaluation of technical information on processes developed/optimized by R&D or "Technical packages".
- Identification of associated quality and regulatory risks
- Management of risk analyses of elemental impurities and nitrosamines
- Writing scientific reports and documents related to your field of expertise
- Elaboration of the strategy for the control of active substances
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
- Skills in organic chemistry
- 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.