Executive - Global Regulatory Operations - Branded
2 weeks ago
Position :
Executive / Sr Executive
Grade
: G12A/ 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
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