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Regulatory Affairs Officer

  • Research & Education
  • 36 hours
  • Pediatrics

  • Closing date 22-12-2021
  • 47.28.21.TS

Job description

  • You will be responsible to perform the regulatory aspects that are associated with the preparation of a phase I-II clinical trial on gene therapy.
  • You will interact with institutional, national, and international organizations to discuss regulatory aspects and you will prepare and file the required regulatory documents.
  • You will provide advice to the principle investigator on regulatory requirements.
  • You will closely interact with the institutional technology transfer office to establish agreements with external parties.

Work environment

The project will be performed within the research group Molecular Stem Cell Biology at the Departments of Pediatrics and Clinical Genetics of the Erasmus MC, which are part of the Center for Lysosomal and Metabolic Diseases, a multidisciplinary center for patient treatment, clinical and basic/applied research.

Erasmus MC stands for a healthy population and excellence in healthcare. By conducting groundbreaking work, we aim to push boundaries through leading the way in research, education and healthcare. We have access to the latest equipment and techniques in a state-of-the-art environment.

Qualifications and skills

  • You have a biomedical background at PhD level and are motivated to perform all regulatory aspects that are associated with the performance of an academic clinical trial on gene therapy.
  • Experience with regulatory affairs in the gene therapy field is preferred but not required.
  • You have excellent verbal and written communication skills. The main language is English; Dutch is preferred but not absolutely required.
  • You are flexible, stress resistant, and able to perform tasks in parallel.
  • You like to work with extensive documents.

Before you apply please check our conditions for employment.

Terms of employment

  • A position for three years, with a possibility for extension. 
  • The gross monthly salary amounts a maximum of € 3.649,- (scale 10.5), depending on your level of education and relevant experience and based on a full-time working week of 36 hours.
  • Excellent fringe benefits, such as a 13th month that is already paid out in November and a individual travel expense package.
  • Pension insurance with ABP. We take care of approximately 2/3 of the monthly contribution.
  • Special benefits, such as a incompany physiotherapist and bicycle repairer. And there is also a gym where you can work on your fitness after work.

Information and application

For more information about this position, please contact Dr. W.W.M.Pim Pijnappel, Associate Professor and head of research group Molecular Stem Cell Biology, +31 (0)10 703 78 64 or w.pijnappel@erasmusmc.nl. Applications should include a curriculum vitae, a motivation of your application, and the contact information of three references.

For queries regarding your application, please contact Alexandra Goud, Recruiter, by phone number: +31 (0)6 256 796 67.

If you are excited by the thought of this position and would like to apply, please do so by using the application form on our website.

No agencies please.

Erasmus MC

Pioneering, pushing boundaries and leading: in healthcare, education and research

Erasmus MC is an international leading academic hospital in Rotterdam. We are recognized as a world-class scientific research organization aiming to improve our understanding of diseases and disorders and helps to predict, treat and prevent them. We have access to the latest equipment and techniques. A working environment that gets the best out of people.

Find out more about Erasmus MC