Sajeev Kumar
Dynamic Regulatory Submission Manager | Global Submissions (FDA, EMA, ROW) | AI-Driven Regulatory Intelligence & Strategy | Veeva Vault RIM | Lorenz docuBridge | eCTD Expert | M.Pharm | Driving Digital Transformation
- Role
- Global Regulatory Submission Specialist at 百时美施贵宝
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sajeev Kumar
Dynamic and detail-oriented Regulatory Affairs professional with expertise in global…
Experience
Global Regulatory Submission Specialist
Nov 2023 — Present · IN
Key Responsibilities:• Provides advice regarding regulatory and submission requirements, dossier content, and formatusing in-depth knowledge of eCTD submission production• Supports the execution of the Global Submission Plan through collaborating with teammembers and vendors and tracks progress of all components for submission to HealthAuthorities for FDA, EU & ROW/WW markets.• Independently facilitate submission team meetings, interacts with responsible parties to aid inensuring that components are received in a timely manner and provide direction to assurequality results are produced• Supports research for legal due diligence activities, document and submission management foracquisitions, partnerships and divestitures, assisting in internal audits and regulatory agencyinspections.• Organize and attend submission team and kick off meetings, represent Submission Manager,drive submission publishing timelines• Facilitate Initial IND Kick off meeting submission.• Track, manage and submits IND, NDA, BLA and Orphan Drug Annual Reports to HealthAuthority.• Tracks, collects, and reviews all components for routine submissions to Health AuthoritiesInteracts with responsible parties for quality submission documents for routine submissions• Troubleshoots issues found in components received and interacts with responsible parties forclarification or revision• Prepare Cover Letters, FDA Forms and submission content plan (Dossier plan) per HealthAuthority requirements.• Perform submission verification on published submissions to confirm eCTD compliant• Update RIM system with US planned submissions and update entries with submittedsubmissions• Coordinate non-eCTD submissions with ISL Intercon Team• Handling potential Investigators and active communication with Clinical Trail Managers forroutine Health Authority submissions.• Performs safety submissions. Review and validate Med-watch data for Health Authority
Education
Andhra University
Bachelor of Pharmacy - BPharm
2015 — 2019
Zilla Parishad High School
SSC
2012 — 2013
AKRG College of Pharmacy, Nallagerla PIN-534112(CC-8N)
Intermediate
2013 — 2015
Andhra University
Master of Pharmacy (pharmaceutics)
2019 — 2021
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