Associate CMC Regulatory Affairs

Daiichi Sankyo Europe, with headquarters in Munich, focuses on protecting people from cardiovascular disease and driving innovation in oncology for solid tumours and blood cancers. The Associate CMC Regulatory Affairs role within the Technology Unit leads preparation of dossiers on manufacturing and testing for development and commercial products. It ensures high quality standards and meets health authority expectations through close interaction with research and manufacturing functions.

The position provides regulatory operational support for development and commercial products across biologics and small molecule portfolios. Embedded in EU RACMC product teams, it supports timely and accurate CMC regulatory product management and compliance to meet project objectives. Daily tasks include authoring CMC documentation, handling health authority queries, and lifecycle management activities.

Responsibilities cover operative support for submissions like Marketing Authorization Applications, Variations, and Renewals. This involves coordination of authoring activities, document logistics, and workflow initiation. The role maintains trustful relationships with health authorities to secure on-time drug approvals and patient supply.

In the EU RACMC Team, the associate contributes to ensuring dossiers align with latest expectations. Interaction with global core documentation and preparation of CTD Module 1 supports commercial product lifecycle. This fixed-term role offers involvement in a portfolio enriching quality of life worldwide.