Advanced Therapy Medicinal Products Compliance Specialist

1 day ago


Fatih, Istanbul, Turkey NES Global Deutschland GmbH NES Fircroft Full time

We are seeking a highly skilled Regulatory Compliance Manager for Advanced Therapy Medicinal Products (ATMPs) to support the establishment of a cell therapy center in our client's biotechnology sector. As a key member of our team, you will be responsible for ensuring compliance with EMA and FDA regulations.

Key Responsibilities
  • Oversee the setup of the cell therapy center, guaranteeing alignment with regulatory requirements for ATMPs.
  • Monitor processes and identify potential issues to optimize production workflows before full-scale operations begin.
  • Promote the optimization and regulatory compliance of daily operations, adhering to GMP standards.
  • Train and guide GMP personnel to ensure adherence to regulatory guidelines and quality standards.

As a successful candidate, you will possess a deep understanding of EMA/FDA regulations concerning ATMPs and have at least 2 years of experience working in a GMP laboratory environment.

Strong analytical skills, combined with excellent organizational and communication skills, are essential for this role. If you are passionate about contributing to the development of cutting-edge therapies in a rapidly evolving field, we look forward to your application.



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