3yrs exp in regulatory operations with hands on experience in Publishing tools like ISI eCTD express, Liquent Insight Publisher, PharmaReady, & Lorenz application apart from the Reg submissions exp.Desired Profile:
eCTD/ CTD/ NeeS submission compilations
Worked on electronic or paper submissions
NDA, IND, ANDA, MAA, CTA, Amendment Submission, supplemental, Variations, Response to HAs, Follow-up measures, Annual Reports
Countries worked US, EU, ROW, International, Australia, South Africa.
Labeling, Structured product labeling, labeling Submission; XML backbone Metadata etc.
Publishing Tools worked on :- ISI publisher , ISI toolbox, ISI eCTD Xpress, Insight Publisher, PharmaReady, Educe, DocBridge, Extedo; eCTD Complier/ Publisher; CH SwissMedic eCTD complier etc.