RA Consultant Global Regulatory Affairs in CMC

For 1 of our clients we are urgently looking for an RA consultant Global Regulatory Affairs in CMC.

  • Do you have at least 5 years’ experience in CMC regulatory affairs?
  • Do you like to work on a more strategic level?
  • Do you have knowledge of vaccines?

Then you are the candidate we are looking for, so please apply today as the deadline for submission is really short!

Job Description 

One of our clients is recruiting for a consultant Global Regulatory Affairs – CMC with a focus on Vaccines. 
Our client develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. 

Responsibilities 

The Consultant, Global Regulatory Affairs – CMC will contribute to the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility is to support the regulatory activities related to vaccines in Europe and US, and specifically to support the preparation of a MAA and BLA. The Consultant will support CMC Teams and provide direction on the interpretation and application of CMC regulations and guidances related to vaccines. Additional responsibilities include: contribute to the preparation and editing of clinical trial applications that include vaccines 

Profile 
  • MSc degree in biological, pharmaceutical, or chemical sciences 
  • 5-8 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience. 
  • At least 5 years of experience in CMC-Regulatory Affairs is required 
  • Knowledge of vaccines required 
  • Strong knowledge of EU and FDA regulations is required. 
  • Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required. 
  • Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs for vaccines highly preferred. - Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred.
Contact Information 

Claire Aerts
+32 15 21 11 04
claire.aerts@valesta.com

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