Senior RA Consultant

What are your responsibilities?

  • You guarantee that the legal requirements regarding (inter)national laws and company standards are met
  • You keep track of the ever-changing legislation in all the regions in which a company wishes to distribute its products and evaluate the impact on the business
  • You align the operation of the departments with the realization of approved strategy, objectives and budget
  • You carry out all negotiations necessary to obtain and maintain a marketing authorization for the products concerned, anticipating the product release
  • You provide regulatory advice to project teams to ensure continued regulatory compliance and timely market release
  • You advise on the legal and scientific restraints and requirements, while collecting and evaluating scientific data
  • You supervise the exchange and presentation of the registration documents to regulatory agencies

Who are we looking for?

  • Master degree in life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer, …) or equivalent through experience
  • +10 years experience in regulatory affairs in life sciences (knowledge of ISO 13485 is a plus) and with sterile production processes (in line with GMP Annex 1)
  • Profound knowledge of the relevant national and international legislation, procedural regulations and technical regulations.
  • Experience of working in cross-functional teams and good people management skills
  • You have an eye for detail and excellent writing and communication skills (Dutch, English and French)
  • You master good organizational skills with a pragmatic, hands-on and flexible approach to your work
  • You are result oriented, motivated and good at coordinating multiple projects and following up with internal/external stakeholders

What does QbD offer you?

  • A young and dynamic company with a 'feel good' culture, an open mind and a 'no-nonsense' approach.
  • QbD really invests in people through training and fun events.
  • A model for competence development, focused on your personal ambitions.
  • A very attractive salary package with many extra benefits, such as a lease car, fuel card, insurance package, meal vouchers, etc.
  • Working for the Flemish Young Entrepreneur of 2019!
  • A flat organization in the broadest sense of the word
  • 32 vacation days
  • In short … We work, we play, we deliver, we are Quality by Design!
Interested? Send your CV and motivation to attention of Elly De Bruyn.
Do you work as a self-employed person, but could you bring added value to our RA projects? We are also open to working with freelancers for exclusively project work within RA.