Regulatory Affairs Assistant

Regulatory Affairs Assistant

For our client specialised in oncology, we are actively looking for a Regulatory Affairs Assistant.

If you are looking for a new opportunity and are interested in RA, don't hesitate to contact me to discuss it!

CareForce One offers Human Resources Solutions in Life Sciences & Healthcare. We work together with you to strengthen your career plan and workforce.

As your co-pilot, we will fly by your side and help give wings to your vision and mission.

Position

The Regulatory Affairs Assistant (RAA) works closely with the Regulatory Affairs Manager (RAM). They ensure that both the clinical trials which fall either under the Directive 2001/20/EC or the EU Regulation N°536/2014 when applicable, and other clinical studies which are run under the internal Sponsorship are authorized and conducted in accordance with the European directives and regulations, international guidelines, and national laws when applicable.

The tasks and responsibilities listed below might not be applicable for all projects, additional tasks and responsibilities might be assigned to the RAA according to his/her skills and qualifications.

Duties and Responsibilities:

  • Compile, submit and follow-up clinical study applications to Ethics Committees and/or Competent Authorities (initials, amendments, end of clinical study if applicable, final study report) in line with regulatory requirements and applicable national laws across different countries;
  • Ensure timely answers to questions raised by Competent Authorities and/or Ethics Committees;
  • Ensure appropriate management of study documents such as filing, processing and quality control;
  • Update and maintain the regulatory specific tracking system;
  • Act as a point of contact for Institut Jules Bordet on regulatory matters;
  • Organize meetings, prepare agendas and minutes;
  • Attend meetings and/or teleconferences on behalf of the RAM.

Requirements

  • Holds a degree in the paramedical, biomedical or scientific field
  • Knowledge of ICH-GCP and legislations applicable to Clinical Studies
  • Relevant experience in the Clinical Research field and in RA are an asset

Skills and competencies

  • English proficiency (written and oral), as well as French and/or Dutch.
  • Advanced Microsoft Office skills
  • Attention to detail and strong organizational skills
  • Advanced writing skills including ability to summarize information
  • Ability to work as a team member or independently with minimal supervision
  • Excellent interpersonal, verbal and written communication skills and strong diplomatic skills
  • Flexible attitude with respect to work assignments and new learning
  • Ability to handle confidential information.

Offer

We can offer you a permanent position full-time with a complete salary package (mealvouchers, free parking, ...)

Start: asap.

Applications

Interested? Don't hesitate to send us your CV at sybille@careforceone.be

See you soon !

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