Regulatory Compliance Officer

Asphalion is growing and we are looking for a Scientific & Regulatory Affairs officer to join our team of CMC unit for the pharmaceutical industry! CMC writing of product specific dossiers (Mod. CMC support during drug development, including roadmaps, gap analysis and writing of CMC sections of IMPDs and INDs.
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RA CMC change control evaluation/management, when necessary.
RA CMC liaison with clinical and non-clinical teams, RA lifecycle management teams, technical/subject matter experts, QA, QC, production and supply, as per project needs.
Successful client management of regulatory affairs.
Responsible for meeting deadlines, ensuring first time quality and maintaining customer satisfaction.
2 years experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and/or Consultancy is required.
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