Regulatory Affairs Manager CMC - San Francisco
2 weeks ago
Job summary
This is a Regulatory Affairs Manager position supporting preparation review submission CMC sections U.S global regulatory filings INDs CTAs amendments BLAs MAAs coordinating internal stakeholders gather technical information ensure accuracy consistency CMC documentation developing maintaining submission plans assigned programs reviewing change controls manufacturing documentation tracking evolving regulatory requirements guidance relevant cell gene therapy manufacturing testing control interacting domestic global health authorities preparing meeting materials responses information requests briefing documents maintaining regulatory databases document systems submission archives compliance internal procedures.
Job description
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