Regulatory CMC lead
vor 1 Monat
This reputable leader in the pharma / biotech space is currently looking for a high achieving Regulatory CMC Snr Manager to join their established and dynamic team tosuport clients with taking complex molecules through development.
This role would suit an expeirenced professional, who likes to work on a variety of projects and molecules.
Responsibilities
- Advise on Regulatory CMC strategies for global projects in various stages of development
- Manage HA interactions (EMA / FDA) for information requests, briefing books and IMPD’s
- Advise project teams on CMC requirements, issues and ways to overcome them
Experience needed
- 5+ years industry experience in Regulatory CMC
- Hands on experience with EMA or FDA
- Proven ability to produce high-quality CMC documentation for complex molecules (including Biologics)
- Experience in CMC development activities
- Fluency in English is essential, other languages are beneficial
- Ability to work in a dynamic company
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