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Job ID :
48250BR
Location :
United Kingdom - Basingstoke
:
Job Description

Job Title: Regulatory Affairs Systems Manager
Location: Basingstoke

About Thermo Fisher Scientific
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $17 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

At Thermo Fisher Scientific Microbiology Division (MBD), we are looking to migrate our paper-based data to a central, electronic repository for key regulatory information that needs to be shared with internal and external stakeholders. The vision is to create a system with a self-service style information system, that is capable of interfacing with existing and new business systems (e.g. SAP) and wherein Regulatory affairs workflows are streamlined and time to market improved by providing users, efficient data analysis, and tracking and reporting tools to replace time consuming and error-prone excel spreadsheets and other manual processes.

The Regulatory Systems Manager role will be the manager of Regulatory Information Management System (RIMS) as well as the owner of any associated business processes. The role will focus on the design and update of the RIMS in order to meet internally and externally driven needs, including interfacing with existing). This role will work closely with the global RA team in MBD It will also include developing processes relative to the needs identified above.


The position holder will report into the Senior Manager, Regulatory Affairs (Europe). The role has no budgetary or line management responsibilities.



Key Responsibilities:
  • Work with MBD IT to lead the full lifecycle of the MBD RIMS, from original idea to proposal to implementation of the system training structure providing users training tracking and audit
  • Project manage and facilitate the migration of relevant data into RIMS
  • Develop business process around the management of the data including change control
  • Propose and implement system enhancements as required for regulatory operations
  • Work with MBD Regulatory Affairs to develop processes and strategy relative to regulatory reporting on key business metrics

Minimum Requirements/Qualifications:

  • Bachelor or Master of Science degree preferably in field of Information Science related to Database Management or Project Management
  • Significant Regulatory system experience in regulated medical industry e.g. pharmaceutical, biologics, or medical devices
  • Demonstrated knowledge and understanding of compliance concepts and developing processes within a regulated industry
  • Highly IT literate – knowledge of various IT systems, data flows, data management, data warehousing and Microsoft Access
  • Ability to make balance decisions in relation to business/customer requirements and offer appropriate advice.
  • Ability to work cross-functionally in a highly matrixed business environment
  • Strong analytical, planning and organizational skills
  • Strong interpersonal and communications skills (oral and written)
  • Ability to travel internationally as required (25%)

*IND-EMEA
*LI-KP1


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