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Job Opening:  Reg Ops Associate RO

Designations
 Reg Ops Associate RO
Job Description
 

 2 in regulatory affairs with hands on experience in Publishing tools like ISI eCTD express, Liquent Insight Publisher, PharmaReady, & Lorenz application apart from the Reg submissions exp.

 
•         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
Desired Profile
 
•         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.

 

Experience
 2+ yrs
Industry type
 
Role
 Reg Ops Associate RO
Functional Area
 Reg Ops Associate RO
Education
 Any Graduate
Compensation
 As per norms
Location
 Bangalore
Keywords
 eCTD/ CTD/ NeeS submission compilations
Contact
 Nirmala
Telephone
 0427-6500385
Email
 nirmala.kn@venpastaffing.com
Job posted
 2013-10-22
Reference
 w-acc-ROAs-mbi
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