Regulatory Compliance Manager for ATMPs

2 days ago


Fatih, Istanbul, Turkey NES Global Talent Full time

For our client, a leading organization in the biotechnology sector, we are seeking a Regulatory Compliance Manager for ATMPs (m/f/d) to support the establishment of a cell therapy center in Istanbul.

Tasks

Responsibilities:

  • Oversee the establishment of the cell therapy center, ensuring compliance with EMA and FDA regulations related to Advanced Therapy Medicinal Products (ATMPs).
  • Monitor processes and identify potential issues to optimize and enhance production workflows before full-scale operations begin.
  • Ensure the optimization and regulatory compliance of daily operations, aligning with GMP standards.
  • Train and guide GMP personnel to ensure adherence to regulatory guidelines and quality standards.
Requirements

Qualifications:

  • A broad understanding of EMA/FDA regulations concerning ATMPs
  • A minimum of 2 years of experience working in a GMP laboratory environment.
  • Strong analytical skills with a focus on identifying and resolving regulatory and operational challenges.
  • Experience in training personnel and promoting a culture of quality and compliance within a GMP setting.
  • Excellent organizational and communication skills, with the ability to lead teams and drive process improvements.

Take this opportunity to contribute to the development of cutting-edge therapies in a rapidly evolving field, working with an innovative and forward-thinking team.

We look forward to receiving your application

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