Regulatory Affairs Officer CMC – Biological products Specialist - Italy

Asphalion is growing and we are looking for a Regulatory Affairs Senior Officer 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: Global CMC writing/management 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 …