Regulatory Affairs Manager

il y a 1 semaine


Brainel'Alleud, Wallonie, Belgique PolyPeptide Belgium Temps plein
Have you been working within the pharmaceutical industry for some time and are you now ready for the next step in your career?_

  • Are you interested in Regulatory Affairs?_
  • Then, here is an opportunity for you_
  • To strengthen its RA team, the PolyPeptide site in Braine L'Alleud is looking for a_

_Regulatory affairs manager_


We are searching for someone with a problem-solving mindset and a "can do" attitude, who is looking for a dynamic workplace in a multi-disciplinary environment.

This is an opportunity to develop in a role that comes with responsibility and where you can make a difference.

Regulatory Affairs is a key function of the PolyPeptide Group with the department in Braine supporting the major production site.

You will be a member of the global RA team with twenty colleagues located over six manufacturing sites.

Job description:

Key duties and responsibilities include:

  • Writing and maintaining regulatory documentation
  • Interacting regularly with customers regarding regulatory documentation and strategies as well as technical issues
  • Communicating with regulatory authorities globally
  • Representing Regulatory Affairs in multidisciplinary project teams

Qualifications:

  • Minimum a bachelor's degree in chemistry / pharmacy
  • Minimum 5 years work experience in RA / QC / QA or in the field of chemical synthesis, pharmaceutical or process development in the pharmaceutical industry
  • High ability to write chemical and technical documents
  • Fluent in French and English, both spoken and written
  • Understanding of Regulatory Affairs environment
  • Mindset for customer service

What we offer is:

- a full time contract
- an attractive salary
- extra-legal benefits and insurances
- a company car
- a challenging position in an innovative and dynamic work environment with an open culture.
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