Authoring and reviewing regulatory sections for vaccine BLA/MAA submissions. Supports External Manufacturing Department in regulatory filing section authoring for vaccine drug substance, drug product and diluent product production. May also review sections and perform data verification to source information. Coordination and preparation of technical and summary reports to support regulatory submissions. Author and review of drug substance, drug product, and diluent process qualification and production filing sections.
https://www.indeed.com/viewjob?t=regulatory+submission+writer&jk=063a4a324e24e37d&_ga=2.2494256.1646275761.1543763749-1408033885.1530798869
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