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Reporting to the Director, Regulatory CMC, the Associate Director of Regulatory CMC will be responsible for the development and submission of regulatory filings for CRISPR/Cas9-based gene therapy projects, in the US and internationally. The individual will help drive the development of innovative CMC regulatory strategies to support regulatory submissions, in close collaboration with the CMC team, the internal technical functions, contract manufacturing organizations, and external consultants and collaborators. This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems, and a range of cell therapy products.
