Regulatory Specialist- CTA Sun Pharma
Sun Pharma
Office Location
Full Time
Experience: 5 - 5 years required
Pay:
Salary Information not included
Type: Full Time
Location: Maharashtra
Skills: Regulatory Operations, Document Management, Process Improvement, CTA applications, CTIS management, eCTD Publishing, Global Regulatory filing requirements, Submission strategy, Clinical Trial Application submission, Data Input, Archival
About Sun Pharma
Job Description
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 CT AManage lifecycle of CTA for all in-house and outsourced activitie sBe the critical technical coordinator for Clinical Trial Application submission and notification/ Request for Information/Information request ensuring accurate and timely input of dat aArchival of necessary submissions and/or document sAssist with definition, development and implementation of processes to meet the evolving CTIS nee dTrack, generate metrics as requested by the Functional Head from time to tim eImplement best practices, participate in process improvements / enhancemen tTo support other Regulatory operations activities including, but not limited to, Clinical Trial Disclosure, eCTD publishing ,,