AstraZeneca Pharmaceuticals LP
Gaithersburg, MD
Jan 09, 2022
Jan 23, 2022
Full Time
Manager, Regulatory Publishing for AstraZeneca Pharmaceuticals LP / Gaithersburg, MD (FT M-F). Obtain & maintain licenses & applics & take responsibility for end-to-end document & submission publishing, incl planning, compiling, publishing, delivering & archiving of regulatory submissions. Reqs: Must have Bachelor's deg. or foreign equiv. in Regulatory Affairs, Life Sci., Engg (any), Tech. or rel + 3 yrs of exp in the position offrd or rel. Must have 3 yrs of exp in the pharmaceutical &/or medical industry in each of the following: Validating applics w/in a regulated envrmt; Drug dvlpmt process, product life-cycle & formatting regulatory submissions; Utilizing regulatory publishing tools incl eCTDXPress, FirstDoc, & ISIToolBox; Providing publishing techn'l expertise to address eCTD techn'l issues impacting global health authority regulatory submissions; Dvlp'g bus. reqmts, test methodologies & training plans for regulatory system upgrade projects; Providing document publishing expertise to cross-functional teams to ensure docs meet the health authorities submission ready stndrd reqmts; Managing delivery & publishing of complex deliverables incl clinical & non-clinical datasets, electronic case report forms, & electrocardiography forms; Addressing issues rltd to regulatory submissions & document publishing thru ServiceNow ticketing system incl system performance, functionality, health authority regulatory reqmts, & user trainings; Driving & implmtg publishing methodologies for the efficient transfer of regulatory info during external collaborations, mergers & acquisitions; & analyzing changing health authority regulatory reqmts & new collaborations btwn health authorities, & implmtg strategic changes to internal publishing tools & processes. Apply: http://www. Enter "R-126552" as the "Keyword," & click "Search Roles." No calls. EOE.