Expert Regulatory Affairs Drug Substance (m/f) Job ID: 10365

Disziplin
Regulatory Affairs
Stellenart
Vollzeit
Unternehmen

Our customer is a well established fast growing specialist for the development and production of chemical and biopharmaceutical ingriedients / APIs. For the Headquarter close to Basel we are looking for a Regulatory Specialist for APIs.

Ihre Aufgaben
  • Represent Regulatory Affairs within Development Projects
  • Managing regulatory dossiers for customer´s products and/or Health Authorities worldwide (focus on EU, USA and Japan)
  • Close cooperation with other departments and customers
  • Responding to Health Authority questions
  • Responsibility for various projects, regulatory dossiers, customer support, and review of GMP
  • Maintenance of Dossiers

 

Ihr Anforderungsprofil
  • Master or PhD in chemistry or comparable life science degree
  • 2-5 years experience in Regulatory Affairs in the area of API development / production
  • Profound knowledge in creation / writing of technical RA-documentation (US DMF, ASMF, CEP, CMC, IMPD and IND) is a must have
  • Expertise in regulatory procedures for EU, USA and Japan
  • Ability to explain chemical and analytical backgrounds
  • Business fluent in English and German

 

Region
Schweiz
Gehalt
Auf Anfrage
Eintrittstermin
Auf Anfrage
Ansprechpartner
Kristijan Curic
Sales Consultant
Fon +41 41 510 04 90
Ansprechpartner
Kristijan Curic
Sales Consultant
Fon +41 41 510 04 90
Mobile +41 79 868 54 81
Mail kristijan.curic@theentourage.ch
Betreff Bewerbung für Job ID 10365 auf theentourage.de