Regulatory Affairs Officer Cmc - Biological Products

Asphalion is growing and we are looking for a Scientific & Regulatory Affairs officer to join our team of CMC unit 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.
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