Regulatory Affairs CMC – Biological products 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 management teams, technical/subject matter experts, QA, QC, production and supply, as per project needs. Independent CMC project management. Su...