Sr. Manager Regulatory Affairs

  • Leiden
  • 4000.00 - 5500.00
  • 32-40 uren
  • WO


Our client is a consultancy in the food and pharmaceutical industry.


Our client is a consultancy in the food and pharmaceutical industry. They participate in very attractive projects for experienced engineers in the pharmaceutical industry. They offer challenging, varied projects with ample opportunities for personal contributions and development.

functie Vereisten

BS in Chemistry/Pharmaceutics or equivalent degree.
8+ years industry experience Pharma, with at least 3 years experience directly in Regulatory Affairs or in CMC Regulatory
Experience with global Regulatory aspects / CMC.
Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.

Wat krijg je?

  • Pensioenopbouw vanaf de eerste dag
  • Collectieve WGA/WIA verzekering
  • NBBU/ABU cao
  • 25 vakantiedagen
  • 8,33% vakantiegeld
  • 100% doorbetaling bij ziekte na één wachtdag
  • Reiskostenvergoeding


This position plays a key role in the Regulatory Affairs department and is responsible for development and successful execution of CMC regulatory strategy and writing of documents (e.g., CMC modules, IND/IMPD CMC documentation) for assigned products.
This position can act as the subject matter expert (SME) for Regulatory and works in close collaboration with stakeholders (e.g., Pharmaceutical Technology including PPM and Manufacturing, Quality Assurance, Business Partners)


Peter Debrichy


Stuur uw cv naar onder vermelding van vacature id (805)

Meer informatie?

Neem contact op met Peter Debrichy van ons kantoor te Zoetermeer, te bereiken op nummer +31 6-10191580