Clinical Operations and Regulatory Science are part of the Clinical Development function. This area also includes pharmacovigilance, clinical science, and biometrics.

Clinical Operations plan, implement, and oversee the clinical studies of in-house products. We ensure studies are conducted and delivered in line with Good Clinical Practice (GCP).

Regulatory Science make sure our product development and manufacturing processes meet the regulations of territories that we plan to supply or work in. The team connect internal and external customers, their products, and worldwide regulatory agencies.

Both teams help evaluate new therapeutic areas and support the operational side of drug development.

As drug development with Advanced Therapy Medicinal Products is so complex, our roles suit scientists with industry experience.

Clinical Operations roles:

  • Clinical Study Managers or Directors
  • Support Specialists
  • Clinical Trial Associates

 

Regulatory Science roles in the regulatory chemistry, manufacturing and control group:

  • Managers, who assist in ensuring regulatory compliance and writing key documentation for regulatory submissions
  • Directors, who provide strategic input and perform key negotiations with regulatory bodies

 

In the wider regulatory group, roles range from apprentices to individuals with extensive product development experience.

All these roles offer interesting and challenging work on exciting, innovative, and world-leading projects. Our team of highly experienced cross-functional experts are great to work with.

 

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