Regulatory Information Management System Manager
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 to join them on a permanent contract.
- Manage RIMS application in compliance with regulatory requirements.
- Managing the Regulatory Information Management System (RIMS) for all products
- Maintaining optimal interface with Global and Local Regulatory Affairs team members
- Coordinating with IT support and external service providers
- Interface with Coordinators to support function for all products.
- Propose/animate/manage evolution of application to improve efficiency and to ensure continued regulatory compliance.
- Manage training support for new users.
- Monitor data entry compliance.
- Propose/manage corrective action plans, if necessary.
- Write SOPs, forms, etc. to describe the day-to-day operations of function.
- Propose/implement process improvements
- Monitor internal and Professional communications concerning relevent regulations (ICH, FDA, EMA …)
- Propose/participate in steps required to maintain regulatory compliance
Your profile :
- BSc, MSc in scientific, IT or administrative discipline or equivalent experience
- 5 years experience Pharmaceutical Industry
- 3-5 years in similar role
- Experience of managing service providers.
- Regulatory affairs processes and EU registration procedures
- Regulatory Information Management systems (Register™ preferred)
- Computer System Validation (CSV)
- Fluent in English