regeneron
USA
The Manager Regulatory Publishing will be accountable for formatting and publishing electronic documents and building regulatory submission results such as INDs, CTAs, BLAs, MAAs & JNDAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, PMDA, ICH, etc) As a Manager Regulatory Publishing, a typical day might include the following: Leads staff and/or vendors who electronically format, publish electronic documents and builds Regulatory submission results. Ensures quality, accuracy, and submission-readiness per Regulatory agency mentorship and specifications, and internal procedures. Provides mentorship to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, PMDA ICH, etc) Provides mentorship on good documentation and submission practices....