This will require an individual who can work cross-functionally and with external stakeholders to translate scientific insights into business outcomes.
A working knowledge of FDA and regulations relevant to the development and approval of new therapeutic agents, biologics and vaccines.
Identify and champion projects in life cycle management, line extension and business development, based on the overall strategy.
Drive preparation, review, and approval of CMC sections of regulatory filings, be the point of contact for interfacing with the regulatory agencies.
This role will be a member of the HilleVax study team and work cross functionally with internal and external stakeholders.
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