Regulatory Affairs Specialist- CTA

Role & responsibilities :-

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,

Note:- CTA and CTIS experience mandatory