CMC Regulatory Affairs Associate Manager

  • Salary: Competitive
  • REF Number: 00055007
  • Consultant: Katie Genever
  • Contact: +44 01438 870022
  • Date Published: 19.01.2023
  • Sector:
  • Location: Basel,
  • Discipline:

Katie Genever is recruiting for a Regulatory Affairs CMC Associate Manager to join a global healthcare company at their site based in Basel, Switzerland on a contract basis, for 18 months with the possibility of extension.

The main purpose of therole will be to:

  • Author high-quality global CMC documentation for regulatory submissions throughout the product lifecycle for Biologics projects/products.
  • Apply agreed CMC global regulatory strategies, current regulatory trends and guide-lines.
  • Coordinate, collect, store source documentation needed for direct submission to Health Authorities.
  • Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Experience in regulatory and/or in the pharmaceutical industry preferred
  • Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the drug development process desirable.
  • Life science degree

This is an excellent opportunity to join a leading healthcare company.

Apply: Please quote job reference 55007 in all correspondence.

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