Junaid Ali Ansari
Regulatory Affairs Specialist | CMC Professional | Post Approval, Annual Reporting & Aggregate Safety Report | Process Trainer | Contextual Master | Expertise in CTD, ACTD, eCTD
- Role
- Regulatory Affairs Specialist at Tata Consultancy Services
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Junaid Ali Ansari
As a Highly Proactive And Dynamic Senior Associate Regulatory Affairs Formulation…
Experience
Regulatory Affairs Specialist
Nov 2022 — Present · Mumbai, IN
Experienced in authoring, compiling, and submitting CMC modules for EU, US, and client-specific regulatory requirements. Skilled in the preparation and submission of aggregate safety reports (PBRER, DSUR, SUSAR) to global markets and regulatory portals such as CESP, MHRA, Eudralink, and ASNM.Proficient in document-level publishing, troubleshooting, and quality control for submission-ready documents in compliance with agency guidelines. Hands-on experience in coordinating translations, assembling submission packages, and collaborating with QA, R&D, and manufacturing teams.Well-versed in global regulatory frameworks and procedures, with practical knowledge of Regulatory Information Management Systems like Veeva Vault. Effectively handles customer and health authority queries, supports lifecycle management, and maintains detailed submission plans and progress updates. Strong communicator with a proactive approach to cross-functional collaboration and team training.
Education
University of Mumbai
Master of Science - MS
Vidya Prasarak Mandals K G Joshi College of Arts & N G Bedekar College of Commerce Chendani Bunder R
PG Diploma
2017 — 2018
Padmashri Annasaheb Jadhav Bharatiya Samaj Unnati Mandals Bhiwandi Nizampur Nagarpalika Arts Science & Commerce College Bhiwandi Dist Thane 421 305."
Bachelor of Science - BS
2011 — 2014
RAMNIRANJAN JHUNJHUNWALA COLLEGE
Master of Science - MS
2014 — 2016
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