Regulatory Information Management System Manager (RIMS)

Regulatory Information Management System Manager (RIMS)

 

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).

 

Responsabilities:

  • 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

 

Requirement:

  • 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
Nabil Belaidi nb@axepta.com

Recruitment and Selection of both Permanent and Contract Information Technology and Business professionals across all sectors in Switzerland. Skills recruited for include (but are not limited to) the following: • Programme/Project Management • IT Infrastructure • Change Management • Desktop/Application/Network Support • Software Development, .Net, Java and PHP developers • Web Designers • Infrastructure Support - 1st -3rd line support through to Windows and UNIX specialists (Redhat, Solaris etc) • Business Analysts and Project Managers • Testers • IT Security • SQL and Oracle DBA’s and Developers • Business Intelligence. • Network specialists (Cisco) • Data Centre engineers Sectors ; Banks, Pharmaceutical, Services companies