about

Function: Regulatory CMC Manager
Location: Basel
Start: As soon as possible
Working hours: Full-time
Type of the contract: Permanent

Contact:
HR-Team Basel
+41 61 205 62 00
recruitment.basel@agap2.ch

your tasks

  • Coordination, preparation, screening and timely creation of CMC registration documentation (especially module 3) for submission and variation dossiers of national and international projects
  • Answering to deficiency letters of regulatory authorities
  • Assuring compliance with regulatory requirements and consistence with external and internal regulatory specifications and quality standards
  • Development of regulatory strategy from the RegCMC perspective
  • Acting as a contact person for RegCMC expertise in cross-functional teams
  • Development and preservation of relationships with regulatory authorities regarding pre-submission strategies, possible registration paths, compliance test requirements, as well as clarification and prosecution of submitted dossiers
  • Preparing and conducting trainings for colleagues with regard to current regulatory standards and best practice

your profile

  • Master diploma, PhD or equivalent in pharmacy, biology, biochemistry or related scientific field
  • Completed first experience in pharma Regulatory CMC for biological products
  • Experience with products / substances in development is a certain advantage
  • English spoken and written mandatory, good knowledge of German a plus

 

At agap2 you will work with a Technical Manager at your side who will follow, support and prepare you for next steps in your career. In addition, you can expect work in a friendly and dynamic team, extensive development opportunities and growing responsibilities.

Please send your application with an updated CV and a motivational letter to recruitment.basel@agap2.ch
Applications from Switzerland and EU only will be considered.