MANAGER, REGULATORY PUBLISHING

Employer
AstraZeneca Pharmaceuticals LP
Location
Gaithersburg, MD
Posted
Jan 09, 2022
Closes
Jan 23, 2022
Ref
001237031102
Function
Management
Hours
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. astrazenecacareers.com. Enter "R-126552" as the "Keyword," & click "Search Roles." No calls. EOE.