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 Senior Business Analyst within the Regulatory Affairs department, you conduct business analysis to support or trigger changes to the Regulatory Information Management (RIM) systems, and you drive end-to-end business change projects with IT systems impact. You review, design and document processes and data for using RIM systems in accordance with existing or new policies, procedures and legislations. You will also be a reference of RA business processes and data related to RIM systems so that you can provide support to end-users
Any projects related to the remit above require a close collaboration between regulatory affairs and IT and a process / requirements analysis.
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 are responsible for driving projects/initiatives end-to-end, from business analysis and impact assessment to implementation and final validation, and consequently you identify all means required to deliver projects successfully
- You communicate and share the outcomes of your analysis, 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 and even guide organizational change
- You participate in business validation of IT systems through User Acceptance Tests, System Acceptance Tests, Data Migration Tests, …
- You become a company's processes and systems specialist and provide business operational support
- Ensure good communication with stakeholders in the project (verbally and written) and collaboration with IT
- University level (IT, Science or Management background) or equivalent by experience
- More than 8 years of similar experience as Business Analyst
- Good leadership skills
- Quickly understand business issues and data challenges of client's organization and industry
- Strong IT background highly appreciated
- Capacity to develop business specifications and requirements
- Great motivation and team spirit
- Customer oriented
- Fluency in spoken and written English
- Excellent communication and presentation skills
- Beneficiary skills/experience (not mandatory but assets):
• Experience with databases used for tracking Regulatory / regulated information
• Experience with document management systems
• Experience with Pharmaceutical Industry, in particular Regulatory Affairs
• Fluent in French.