business meeting, meeting, business-5395567.jpg

Regulatory Affairs Director

The company we are recruiting for, is a growing Belgian consulting company that focuses on supporting pharma companies in Regulatory Affairs, Market Access, and Medical Affairs across the BeNeLux and Nordics regions. They are at a pivotal point in a transformation towards a fully integrated and cross functional agency with international footprint.

They work closely with pharmaceutical and device companies, start-ups, universities, and they are partners to the major healthcare associations. In addition to the contacts with clinical experts, their associations, and patient advocacy groups, the company also has regular interactions with key stakeholders at the Cabinet of Health and Social Affairs, FOD Economy, RIZIV, FAGG, Sick Funds, and the Belgian Federation of Hospital pharmacists (BVZA-ABPH).

You will be part of a very dynamic and innovative group of driven professionals. The team is dedicated and result driven and focused on long term relationships in changing market dynamics. They all have an open ‘growth’ mindset, stimulating each other to keep evolving both personally and professionally.

About the Job

You will be responsible to build up and lead an operational RA team focussing on Regulatory, Pharmacovigilance, QA and Compliance activities for the pharmaceutical and medical device clients in Belgium, the Netherlands, and the Nordic countries. You will also be part of the management team and contribute to the future growth of the company.

About you

  • Strong networker with ability to influence internal and external stakeholders.
  • Dynamic and ambitious professional.
  • Hands-on strategic & innovative thinker.
  • Team player – accountable and entrepreneurial.
  • Able to manage multiple tasks in a complex environment.
  • Excellent stress and time management and ability to handle priorities and deadlines.
  • Detail oriented.

About your knowledge, skills, and experience

  • Master/PhD degree in Pharmaceutical sciences with minimum 5-10y of experience in RA/QA environment in pharmaceutical or medical device industry.
  • QA/QP with GMP/GDP experience
  • Having EU MDD/MDR experience is a benefit
  • Senior level experience in technical regulatory knowledge of local/EMA regulatory requirements (eCDT dossiers/MA dossiers) is mandatory
  • Senior level experience with local / EU GVP requirements
  • Languages: Dutch/French/English (by preference native French or Dutch).
  • Living in Belgium or the Netherlands.

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!