Job Description
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!
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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, whe...