Regulatory Affairs CMC – Biological products Consultant

Regulatory Affairs Consultant / Senior Consultant

Asphalion is growing and we are looking for a Regulatory Affairs Consultant / Senior Consultant to join our CMC unit of consultants for the pharmaceutical industry . Someone who loves to take on new challenges, to work in an international environment and who wants to grow with us!

Main responsibilities

• CMC writing of product specific dossiers (Mod. 2/Mod. 3), with special focus on biologics (including ATMPs and Biosimilars), for new registration applications and variation packages mainly in EU and US markets.
• Support in responses to deficiency letters, including coordination and preparation of responses.
• CMC support during drug development, including roadmaps, gap analysis and writing of CMC sections of IMPDs and INDs.
• RA CMC change control evaluation/management, when necessary.
• RA CMC liaison with clinical and non-clinical teams, RA lifecycle manage...