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Job Opening:  Hawk Reg Ops Associate

Designations
 Hawk Reg Ops Associate
Job Description
 

 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.
 
Experience
 3+ yrs
Industry type
 
Role
 Hawk Reg Ops Associate
Functional Area
 Hawk Reg Ops Associate
Education
 Any Graduate
Compensation
 As per norms
Location
 Bangalore
Keywords
 ISI eCTD express, Liquent Insight Publisher, PharmaReady, & Lorenz application
Contact
 Nirmala
Telephone
 0427-6500385
Email
 nirmala.kn@venpastaffing.com
Job posted
 2013-10-23
Reference
 w-acc-hawk-blore
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