Regulatory Affairs Business Analist
As a Business Analyst within the Regulatory Affairs department, you conduct business analysis to support or trigger changes to the Regulatory Information Management (RIM) processes and systems. You review, design and document processes and data for using RIM systems in accordance with existing or new policies, procedures and legislation. You will also be a reference of Regulatory Operations business processes, in particular Submission Delivery, so that you can provide support to end-users.
You will be, in particular, involved on the Brexit impact analysis and in the implementation of changes in Processes and Systems related to Submission Delivery (Clinical Trial Applications, eCTD Publishing, Market-Specific Requirements…)
Business Analyst for Submission Delivery team within Global Regulatory Affairs.
- 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 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 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
- University level (Science, Management or IT background) or equivalent by experience.
Skills & Experience
- Between 2 and 5 years of similar experience as Business System Analyst
- Good leadership skills
- Quickly understand business issues and data challenges of client's organization and industry
- Capacity to develop functional specifications and system design specifications
- Great motivation and team spirit
- Customer oriented
- Fluency in spoken and written English
- Excellent communication and presentation skills
- Experience in Pharmaceutical Industry, in particular Regulatory Affairs
Beneficiary skills/experience (not mandatory but assests)
Experience in Pharmaceutical Industry, in particular Regulatory Affairs
Working as a consultant for XPE Pharma & Science means that you will be a part of the Adecco group. You will be guided and be followed-up by one of our Talent Managers. While giving the best of yourself at your project you will be able to develop your soft & hard skills as well via our Talent Managers.
Do you need more information?
Contact me at 010/80.71.15
Ready to apply? Please send me your CV and your cover letter for this position: Andrea.Baetens@xpegroup.net