Regulatory Affairs Officer CMC – Biological products Specialist - Portugal

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 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, Q...