Position               :  Executive / Sr Executive

Grade                   :  G11A/ G11B

Job Location       :  Gurgaon (preferable)/Baroda/Mumbai

Education            :  M.Pharm

 

Department       :  Regulatory & Business Continuity - Branded

 

Candidate shall be responsible for assuming the role for the assigned specialty programs (NCE/BLA) who shall be responsible for regulatory operations activities including but not limited to CTA applications(in EU, LATAM , USA, Canada, ROW) , CTIS management, submission management, eCTD publishing of all modules, document management etc. Must understand and be updated with current Global Regulatory filing requirements and eCTD /CTIS structure.

 

Collaborate with Strategists (Leads) and coordinators for submission strategy and timelines. Prepare Regulatory Management Plan, Submission content plan for CTA Manage lifecycle of CTA for all in-house and outsourced activities Be the critical technical coordinator for Clinical Trial Application submission and notification/ Request for Information/Information request ensuring accurate and timely input of data Archival of necessary submissions and/or documents Assist with definition, development and implementation of processes to meet the evolving CTIS need Track, generate metrics as requested by the Functional Head from time to time Implement best practices, participate in process improvements / enhancement

To support other Regulatory operations activities including, but not limited to, Clinical Trial Disclosure, eCTD publishing