Senior Regulatory Affairs - Business Analyst

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.

Function Description:

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,

Ensure good communication with stakeholders in the project (verbally and written) and collaboration with IT

Education:
University level (IT, Science or Management background) or equivalent by experience.

Skills & 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

Autonomous

Fluency in spoken and written English

Excellent communication and presentation skills

LOCATION

Wavre, Walloon Region, Belgium

DURATION Full–time / contract

SALARY Attractive salary plus benefits

TO APPLY If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Treasa Alterskye on (0) or e–mail on If this role isn't suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!