Posted to MedZilla on 5/25/2017


Germany, Regulatory CMC Consultant RA_PD_12011-MZ


Here is a great opportunity to join a rapidly expanding global biopharmaceutical company, that is dedicated to being leaders in innovative medicines and vaccines. The company is seeking a Regulatory CMC Consultant to join their team in Hamburg, Germany. 

Job Role and Responsibilities:

  • Submission of Chemistry, Manufacturing and Controls (CMC) elements of biologicals (allergen products)
  • Prepare, review and assemble relevant documents with regard to dossier maintenance.
  • Work closely with authors of dossier sections and prepare/review CMC regulatory filings to health authorities (mainly europe)
  • Evaluate Change Requests in the Change Control process

Experience and Skills:

  • Practical experience in CMC lifecycle documentation and biologicals
  • Experience in Biologcial medicinal products - 6 years plus
  • CMC, Module 3,2,3 - 6 years plus
  • RA experience - 5 years plus

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website -
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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