Regulatory Compliance Specialist for ATMPs mfd
Regulatory Compliance Specialist for ATMPs mfd
Posted on :
20-01-2025
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1 Vacancy
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Job Description
For our client a leading organization in the biotechnology sector we are seeking a Regulatory Compliance Specialist 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 fullscale 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 cuttingedge therapies in a rapidly evolving field working with an innovative and forwardthinking team.
We look forward to receiving your application!
Employment Type
Full Time
Key Skills
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