freelance
Regulatory Process Business Analyst Reference number: 1515
Published: 24-08-2020, 12:39
Region: Wavre
Sector: Pharma
Job description
Mission Context:
The Regulatory Affairs (RA) department manages all activities related to regulatory data and information management with worldwide health authorities. To make this activity possible, a large amount of IT applications are used, e.g. a database for tracking regulatory activities.

As a Business Analyst within the Regulatory Affairs department, you conduct business analysis to support or trigger changes to the Regulatory Information Management (RIM) systems. With your expertice on RA process you will help defining Acceptance criterias and defining formal testins in order to ensure that the new RIM solution will cover the E2E regulatory process and ways of working applied within RA and assess the most logical and efficiency way in order to meet business and compliance needs.

Function Description
Business Analyses with Stong Regulatory Process expertise ensuring the formal testing of the E2E Regulatory process for the implementation of the new Regulatoty Vault Solution and authoring the training material and Quick references guides.
What you’ll do
  • You analyze and understand business processes and information, and you identify and propose possible improvements, in accordance with regulatory processes and legislation
  • You identify, gather, analyze and document business requirements and needs of clients, stakeholders and management, using document analysis, interviews and workshops. You ensure that requirements and needs are clear, complete and unambiguous.
  • You prepare the acceptance criteria and user stories for E2E Regultatory process and way of working with the new RIM solution , and get appropriate validation
  • You collaborate with project teams and get input from Subject Matter Experts when necessary
  • You interact and communicate with stakeholders within your department as well as in any other department involved in your projects
  • You participate for authoring of the quick refrence guides and training materials of the new RIM Solution based on the defined E2E process and Way of Working
  • You participate in business validation of IT systems through User Acceptance Tests, System Acceptance Tests, Data Migration Tests, …
  • You become a RIM processes and systems specialist and provide business operational support
  • Ensure good communication with stakeholders in the project (verbally and written) and collaboration with IT
Profile
  • Knowledge of regulatory affairs and a variety of regulatory submissions and processes (e.g. Submission planning & Tracking, regulatory Submission Strategy, regulatory authoring documents, etc).
  • Experience in the Pharmaceutical Industry with an experience within a RA or Project Management Environment
  • Quickly understand business issues and data challenges of client's organization and industry
  • Testing & Validation expertise background highly appreciated
  • Capacity to develop business specifications and requirements
  • Fluency in spoken and written English
  • Soft skills:
    Excellent communication and presentation skills
    Great motivation and team spirit
    Customer oriented
Required Skills
  • Experience:
    Similar experience as Business Analyst
    Experience with databases used for tracking Regulatory / regulated information
    Experience with document management systems
    Experience with Pharmaceutical Industry, in particular Regulatory Affairs
  • Education : University level (Science or Management background) or equivalent by experience
  • English Fluent
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