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Regulatory Affairs Officer

10/02/2020
- Zaventem

Company information
Job content

Within the departement of Contract Operations Quality Assurance, we are looking for a Regulatory Affairs Officer. This departement is primarily occupied enhancing the quality of (animal) health products through quality management of outsourcing activities and assessment of suppliers. 

You will be responsible to ensure and maintain regulatory compliance for contracted products by liaising with the Contractor Quality Lead with responsibility for the quality oversight of assigned contractors, the contractors themselves and with Regulatory Affairs colleagues in charge of the maintenance of the registration dossiers. You will assist the Team Leader in developing and maintaining processes to ensure compliance and will work in close collaboration with other colleagues.

MAIN AREA’S OF RESPONSIBILITIES:

  • Contractor Change Management: Ensure an efficient change control process for contractors
  • File Compliance: Support compliance of product registrations to national, regional and GMP requirements
  • Regulatory response: Manage requests for regulatory support
  • Product transfers (PNS) and New Product introductions
  • Development and Implementation of ESQA Guidelines, policies and initiatives:
Profile
  • Higher National Diploma  in a Pharmaceutical Science, Pharmaceutical Technology, Chemistry, or Microbiology or equivalent through practical experience
  • 3 years experience in regulatory affairs environment or equivalent through experience
  • Experience with Trackwise is a plus
  • Good knowledge of Word, PowerPoint, Excel
  • Fluent in English and ideally knowledge of more European languages
  • Demonstrate knowledge  of general regulatory requirements
  • Prepared to take initiatives, perseverance, good communication skills
  • Ability to handle emerging issues and manage situations until guidance can be obtained
  • Diplomatic in communication with internal and external customers
  • Customer oriented
What do we offer?

We offer a full time position in an international environment with an attractive salary package.

Contact

For more information, contact Marieke Franken +32 16 30 95 09 or marieke@arcq.be.