Sr. Manager Regulatory Affairs

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

Opdrachtgever

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

Opdrachtgever

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

Werkzaamheden

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)

TAGCLOUD

Peter Debrichy

Geïnteresseerd?

Stuur uw cv naar peter@tailorminds.com 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

SOLLICITEER MET ONDERSTAAND FORMULIER

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