Regulatory Business Process Analyst
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:
- The global regulatory information management systems (RIMS), which support the overview of all Norgine’s products and registrations worldwide and supports the planning and tracking of all key regulatory activities.
- The global electronic document management system (EDMS), which supports the creation, review, approval and lifecycle management of regulatory submission documents and supporting documents for worldwide submissions. Working closely with the Regulatory Systems Operational Analyst and Associate Director Regulatory Information Management, the Regulatory Process Analyst role is responsible for understanding the workings of organization-wide Regulatory Affairs processes and systems to enhance and maintain them. This position will have the direct daily contact with the global users, support their use of and work to optimize the business process. The Regulatory Process Analyst will document, review and maintain Regulatory Affairs business processes and is required to make suggestions for simplification/improvements to current ways of working to enable more efficient and effective processes.
DUTIES & RESPONSIBILITIES:
- Work closely with Regulatory Affairs to identify, analyse and improve core business processes and workflows
- Work with stakeholders to identify, analyse and improve touchpoints with Regulatory Affairs processes and workflows
- Facilitate meetings and workshops with subject matter experts to document and analyse processes and workflows
- Develop and maintain clear and detailed Regulatory Affairs process maps and Regulatory Affairs business requirements. Partner with process owners and provide SME advice on best practice for process maps.
- Develop and maintain SOPs, Work Instructions and training materials which clearly describe RIMS processes and work flows. Partner with process owners and provide SME advice on best practice for process maps.
- Lead regular impact assessments of new Veeva RIMS functionality, providing support and advice to Regulatory Systems Operational Analyst and IT. Partner with Associate Director, RIMS to determine configuration changes which should be adopted.
- Provide SME input to the development of UAT and PQ scripts, ensuring systems support Regulatory Affairs processes
- Ensure alignment between system and process by partnering with the Regulatory Systems Operational Analyst and business process owners to gather user requirements and propose new system functionality
- Facilitate Norgine Veeva RIMS Super User Network
- Develop and maintain Veeva RIMS user support materials, such as Core Training Materials, How To Videos, Knowledge Bank items, etc.
- Monitor current business processes for effectiveness and compliance. Suggest opportunities for improvement and LEAN processes.
- Lead / Participate in RIMS and IDMP project teams as required.
- Bachelor’s degree in Computer Science, Business Administration, or related technical field or equivalent experience
- 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
- Strong skills in Process Mapping, Business Process Reengineering and LEAN
- Strong analytical skills with a demonstrated ability to extensively analyse business processes and workflows
- Experience facilitating workshops and focus groups
- Experience developing business requirements
- Experience developing instructional and procedural documentation and presentations
- General knowledge and understanding about pharmaceutical sciences including standardization (Pharmacopeia, Standard Terms, ISO IDMP, etc)
- Experience utilizing electronic document management systems, regulatory publishing systems and/or regulatory tracking databases
- Ability to simultaneously manage projects
- Demonstrated client relationship skills and the ability to maintain self during challenging situations
- Familiarity of GxP, Annex 11 and 21 CFR Part 11 computerized systems
- High level of competence in MS Office Tools (Word, Excel, Project, PowerPoint, Visio, SharePoint)
- Practical operational experience of working across disciplines and across multiple regions/countries
- Team player with excellent interpersonal skills
- Self motivated and ability to work autonomously and within a team