My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton. Due to this growth my client is looking for a Regulatory Information Management System Manager (RIMS).
- Maintain RIMS in a compliant and validated state
- Provide direction and best practices to external provider
- Establish and coordinate training strategy for end users
- Interface with Operations to assure data sharing with ERP systems
- Establish KPIs to measure RIMS data quality/usage
- Keeping up to date with changes in regulatory legislation and guidelines
- Optimize and simplify the process of handling and tracking post approval changes transformation project
- Maintain SOPs, instructions … related to RIMS.
- Propose/implement process improvements
- Regulatory affairs processes and EU registration procedures
- Regulatory Information Management systems (Register™ preferred)
- 5+ years of prior regulatory experience
- Ability to grasp new concepts quickly and to assimilate and evaluate scientific data
- Strong IT skills, particularly in relation to using databases
- Fluency in English