MANAGER, REGULATORY AFFAIRS

Manager, Regulatory Affairs for AstraZeneca Pharmaceuticals LP / (FT; Gaithersburg, MD) manage Clinical & Patient Safety documentation & submission components across each product lifecycle. BA or equiv in Reg Aff, Tech or a rel + 3 yrs exp in role or rel. in IT healthcare or pharm w/ Driving major drug submission & IT enablement projects across functional project teams; Change Request Mgmt of Regulatory Info Mgmt Systems incl analyzing system reqmts, reviewing use cases & system test scripts, dvlp'g User Acceptance Testing (UAT) & Operational Qualification (OQ) test scripts, managing communication plans & risk logs & supporting post implmtn project needs; Dvlp'g Regulatory Submission methodologies thru analysis of eCTD v4.0, Project Orbis, RTOR, & Brexit; Dvlp'g Submission Publishing internal & external training methodologies; Managing regulatory submissions for medical devices & combo products; & Publishing stndrds for Case Report Forms (CRFs) & engaging w/ Prgmg to manage datasets & adjudication packages prior to submission publishing. ER will accept MA in lieu of BA. ER will accept pre or post MA exp. AstraZeneca reqs all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as req'd by applicable law. APPLY: http://www. astrazenecacareers.com. "Search jobs," enter "R#140263" as the "Keyword," & click "Search." No calls. EOE.