Regulatory Business Process Analyst

Harefield, England, United Kingdom · Regulatory Affairs

Description

The Regulatory Information Management Team is responsible for the administration, maintenance and process support of all processes and systems owned by Regulatory Affairs such as:

DUTIES & RESPONSIBILITIES:

Requirements

  1. Bachelor’s degree in Computer Science, Business Administration, or related technical field or equivalent experience
  2. 5 years experience as a Business Analyst, on large and complex projects with 3 years experience in Regulatory Affairs or Regulatory Operations within the pharmaceutical industry
  3. Strong skills in Process Mapping, Business Process Reengineering and LEAN
  4. Strong analytical skills with a demonstrated ability to extensively analyse business processes and workflows
  5. Experience facilitating workshops and focus groups
  6. Experience developing business requirements
  7. Experience developing instructional and procedural documentation and presentations
  8. General knowledge and understanding about pharmaceutical sciences including standardization (Pharmacopeia, Standard Terms, ISO IDMP, etc)
  9. Experience utilizing electronic document management systems, regulatory publishing systems and/or regulatory tracking databases
  10. Ability to simultaneously manage projects
  11. Demonstrated client relationship skills and the ability to maintain self during challenging situations
  12. Familiarity of GxP, Annex 11 and 21 CFR Part 11 computerized systems
  13. High level of competence in MS Office Tools (Word, Excel, Project, PowerPoint, Visio, SharePoint)
  14. Practical operational experience of working across disciplines and across multiple regions/countries
  15. Team player with excellent interpersonal skills
  16. Self motivated and ability to work autonomously and within a team


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