Regulatory Compliance Manager for ATMPs (m/f/d)

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.

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.

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!