REGULATORY AFFAIRS OFFICER

DiegemIPharmaceutical Sector

Job description

For one of our pharmaceutical clients in Diegem, we are currently looking for a REGULATORY AFFAIRS OFFICER.

As REGULATORY AFFAIRS LIAISON you have the following responsibilities:

  • Assist and support the team members in the execution of regulatory strategies impacting all CSS for MDR Implementation and Execution 
  • Assist in the execution of regulatory strategies for non-EU countries, including coordinating and tracking document requests 
  • Create and approve ECOs pertaining to the Coordinator’s projects and duties (including but not limited to SOP's, EU labeling approval)
  • Gather and assemble data necessary for the development of the regulatory aspects of project plans including tracking, planning and communication
  • Assist in the development of best practices for Regulatory Affairs processes
  • Researches, collects data, and responds to requests from internal colleagues
  • Responsible for administrative tasks to support the CSS MDR activities including preparation of meetings and general administrative activities
  • Responsible for communicating business related issues or opportunities to next management level 
  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Perform other duties assigned as needed 
Profile As REGULATORY AFFAIRS OFFICER you match the following requirements:
  • You have a bachelor or master degree with a first work experience, preferably but not limited to regulatory affairs
  • You possess excellent written and verbal communication skills in English
  • You have creative and good computer skills: Outlook, Power Point, One Note, Excel
  • You work detail oriented, conscientious and autonomous
  • You are able to take on diverse tasks
  • You have good organizational skills
  • You can work in and with a diverse team 
Organisation and department description

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

Offer

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Any questions?
Marlies Collart Consultant Life Sciences Select Projects +32 3 203 50 80
REGULATORY AFFAIRS OFFICER Vacancy information
74643
Life Science I R and D - Science and Scientific Research
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