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Regulatory Submission Officer

Belgium, Vlaams Gewest, LeuvenClinical development & Regulatory

Job description

With the launch of our rapid COVID 19 PCR test, we are currently seeking a Regulatory Submission Officer to join our “Clinical Development and Regulatory Affairs” team. You will be an active part in accomplishing our goals and in our company’s success.

As our Regulatory Submission Officer, you will manage regulatory submission activities from compilation of product technical file, submission to agencies and through the approval process, ensuring that files are prepared to the highest quality standard and in a timely efficient manner.

Your responsibilities will be:

  • Prepare, review, and submit product technical file applications to EU and international regulatory agencies.
  • Work closely with R&D and other functional area experts to compile documents needed for a submission, manage and track document upload.
  • Perform detailed review of available outputs to ensure compliance with Regulatory standards and Health Authority guidance.
  • Advise on changing regulations and compliance requirements.
  • Track submissions and ensure timely filing of documents.
  • Communicate appropriately with Notified Body to assure timely review process and follow-up on product changes.
  • Be our spokesperson at audit

Job requirements

  • Bachelors' or Masters’ degree in a scientific discipline or equivalent by experience;
  • We welcome young graduates. If you have a few years (1- 3 years) of prior Regulatory Submission experience in the pharmaceutical industry , IVD industry or the medical device industry it is an asset;
  • Critical thinking to identify the alternative solutions by analysis of strengths and weaknesses;
  • Excellent oral and written English skills;
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation;
  • Good communication and presentation skills are a must;
  • Excellent organization skills and efficient time-management;
  • Team player attitude;
  • You feel comfortable in a start-up environment and you can easily switch from one task to another;
  • You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues;
  • Our offices are located in Leuven (Belgium). Relocation to Belgium is needed. It is essential that you hold entitlement to work and live in Belgium.