pharmacy 3377670 480

Regulatory Affairs Officer

With an offering for just about every therapeutic area, this company is a leader in generic medicines and OTC products in Belgium. They still produce many medicines and food supplements in Belgium. They currently have 180 employees and continue to invest.

Our culture is characterized by the strong commitment of our employees. Are you entrepreneurial and would you like to work for the largest and fast-growing pharmaceutical company in Belgium?

 

About the Department Pharmaceutical Affairs

The Pharmaceutical Affairs (PA) Department consists of Regulatory Affairs, Quality Assurance, Medical Affairs and Pharmacovigilance. The department ensures that the products are produced and delivered to customers according to the highest quality and safety standards and complying with the local and EU regulatory requirements.

 

About the role

The Regulatory Affairs Officer (RAO) is responsible for managing the lifecycle of the medicines from the preparation of the registration dossier, including the follow-up and finalization of new registrations, the preparation to market access, compilation, submission, and follow-up of variation dossiers in Belgium and Luxembourg.

 

Also managing the lifecycle of non-medicines (e.g. food supplements and medical devices) by preparing, compiling, submitting and following up the notification files in Belgium and Luxembourg.

 

The RAO will provide administrative assistance to internal stakeholders (including Supply Chain Department, Sales and Marketing Department) and external customers (including regulatory authorities and professionals in the medical-pharmaceutical world) to ensure a smooth launch and continuity of the products on the market and good sales.

This role is part of a team of 4 Officers and reports to the Regulatory Affairs Manager.

 

Required profile

  • Degree in a scientific or (bio-)medical education (e.g. Pharmaceutical Sciences/Pharmacist, Bio-medical sciences, Drug Development or equivalent)
  • Relevant work experience: 0-4 years is a plus
  • You’re open-minded, collaborative, team player, ready to adapt to the changing needs
  • You’re curious about new techniques and tools, and eager to always keep learning
  • You have good organizational and planning skills
  • Knowledge of pharmaceutical terminology is a plus
  • You are fluent in Dutch, French and English
  • We hire for attitude!
  • The company expects from the employees to be Motivated, Energetic and Passioned by their job
  • You act in line with our values: Integrity, Entrepreneurship and Agility

Want to take this challenge?

Send your resume to roxane@nuwhi.be or to liske@nuwhi.be and tell us a little more about yourself. We hope to hear from you soon!