Regulatory Compliance Manager

4 dagen geleden


Utrecht, Utrecht, Nederland Proclinical Staffing Voltijd

Job Overview:

We are seeking a Regulatory Compliance Manager to join our team at Proclinical. In this role, you will be responsible for ensuring that our client's development and manufacturing processes comply with regulatory standards and good scientific practices.

You will work closely with cross-functional teams to identify and mitigate risks, and develop strategies to maintain compliance.

Key Responsibilities:

  • Develop and implement regulatory compliance strategies to support biotech and pharma clients.
  • Collaborate with cross-functional teams to ensure seamless project execution.
  • Provide scientific and technical input for CMC development plans and reports.
  • Maintain up-to-date knowledge of regulatory guidelines and industry trends.

Requirements:

  • Master's degree in a relevant biomedical field.
  • Experience in CMC within the biotech or pharma industry.
  • Familiarity with antibody development and manufacturing processes.
  • Understanding of quality systems such as GMP, GLP, and GDP.


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