(Associate) Director Regulatory CMC

BioTalent are partnered with a rapidly growing, innovative, commercial stage Global Biotech in their search for an (Associate) Director Regulatory CMC. Candidates should have at least 9 years of experience in regulatory CMC from a drug development standpoint, with at least a few years in the development of Biologics, mRNA, or vaccines. The role will be responsible for Regulatory CMC strategy and development activities for a portfolio of mRNA / biologic / cell therapy products. Requirements: At least 9 years of experience in the regulatory CMC development (including at least some biologics/CGT/mRNA/vaccines) Experience in authoring IMPDs, INDs, Module 3 etc. Experience in liaising with Health Authorities in the EU (US experience would be a bonus) Clear communicator with very strong technical experience and in-depth knowledge of regulations. The role can be worked remotely from Germany, the United Kingdom, or East Coast US as long as candidates are legally allowed to work in those locations. GatedTalent consolidates jobs from a variety of sources. Users of the “Talentis” and “FileFinder” executive search CRMs are able to publish jobs to the site with links from inside their core business apps. These are supplemented by jobs added by our own researchers and those provided by a third party job aggregation service. Please note that GatedTalent staff are not directly involved in the recruiting process.
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