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Experienced RA Associate

Keyrus Biopharma

Belgium

Job Description

  • To reinforce our Clinical Development Business unit, RA department, we are looking for an Experienced Regulatory Affairs Associate;
  • The Regulatory Affairs Associate (RAA) is responsible for reviewing the compliance of the regulatory documents required by the different EU authorities; she/he is responsible for managing and submitting the clinical application dossiers to the authorities in support of new product development activities. The RAA should report to a RA Manager.

Main duties:

  • Respond to routine regulatory queries for information and documents;
  • Stay at the forefront of evolving regulatory requirements and be proactive in maintaining compliance;
  • Prepare, review and submit regulatory clinical trial application and notifications;
  • Compilation of electronic reports using available electronic publishing tools;
  • Communication with authorities;
  • Respect of quality commitments;
  • Participating in the continual improvement of the Quality System.

Profile

Required skills and qualities and expected level:

  • At least 2 years’ experience in a similar position with CTA activities;
  • Perfect knowledge of the regulatory requirements and legislation of EU authorities;
  • Knowledge of CTA European format;
  • Knowledge in the use of document management and publishing tools;
  • Excellent knowledge of GCP, GMP and ICH guidelines;
  • Computer proficiency and adaptability working with a variety of databases, word processing, etc.;
  • Concern for quality and compliance; integrity and consistency;
  • Strong organizational skills;
  • Ability to work in a team environment with shifting priorities and requirements;
  • Good communicator;
  • Excellent English level both written and verbal.

Required level of education:

  • Ph.D. or Master’s degree in scientific discipline or four years related experience or equivalent combination.

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