Director CMC
Director CMC
Eisai
United Kingdom
Your new role
As a Director, CMC you will be responsible and accountable for CMC sections of Eisai regulatory submissions related to biologics products (clinical and commercial stage), all regions globally.
Main duties include, but not limited to:
- Manage, prepare, finalise CMC sections of EU IMPD/MAA and rest of world equivalent documents.
- Oversee teams preparing content, arrange reviews by regulatory, SME peers, senior management, ensure on time delivery of high-quality submission documents.
What are we looking for?
- Demonstrated experience with preparation of major biologics submissions, multiple IMPD submissions, MAA submissions.
- Demonstrated experience with biochemistry, especially antibody and immune system biological processes.
- Advanced degree preferred.
Don't forget to mention EuroPharmaJobs when applying.
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