Vijay Pal Bhati
New Delhi
Summary
Regulatory and compliance professional with over 13 years of experience in submissions. Proven track record of managing teams and achieving goals in fast-paced, deadline-driven environments. Strong ability to build productive working relationships and demonstrate ownership in projects. Committed to exceeding company expectations through exceptional work ethic and initiative.
Overview
2026
2026
years of professional experience
Work History
Manager
AstraZeneca Private India Limited
Delhi
12.2024 - Current
- Filed Global Clinical Trial Applications for Biologicals with CDSCO for Oncology and BBU Portfolio.
- Reviewed accuracy and quality of submitted dossiers to ensure compliance.
- Moderated Subject Expert Committee Meetings, addressing queries from SEC members and CDSCO officials.
- Managed Import Licenses for approved clinical trials, strategizing on ad-hoc requests during drug shortages.
- Oversaw lifecycle management of approved clinical trials, including CT-NOC compliance and protocol amendments.
- Coordinated preparation and submission of query responses in collaboration with cross-functional teams.
- Conducted Regulatory Intelligence activities, performing trend analysis of evolving regulations.
- Managed databases such as Vault RIM and REACT2 for efficient data handling.
Deputy Manager
Biocon Ltd
Delhi
06.2019 - 12.2024
- Compilation, review and online submission of Market Authorization Applications for New Drug as per NDCT Rule, 2019 (Form CT-21).
- Compilation, review and submission of applications as per guideline of CDSCO i.e. Registration certificate, import (CT-18) SAE, Medical device, Loan Licence, New Drugs, SNDs, FDC, Pharmacovigilance, Biologicals, import, BE export NOC (Form CT-05, MD-16 and Form CT-16), Test Licenses, Form CT 10, Form CT 12, Form CT 13, Clinical trials, PSUR, Written confirmation certificate, PI mapping.
- Liaising with Regulatory Authorities i.e. CDSCO and its offices, CBN, RCGM, IPC, NIB, Government Labs and NPPA to ensure proper tracking and timely processing of applications.
- Execution of online submissions of applications on Sugam Portal. Prepare and submit the query responses as and when required online.
- Drafting package insert and label as per NDCT Rule and finalization with help of artwork team.
- Compilation and online submission applications pertain to R&D, preclinical study, export, import and transfer of GMOs/LMOs to RCGM/IBSC as per DBT Guidelines.
- Coordination for SEC meeting to ensure timely and smoothly deliberation proposals.
- Preparation and submission application for import of Narcotic substances to CBN, Gwalior as per NDPS Act 1985.
- Tracking, coordination and submission of compliance.
- Coordination with cross-functional team providing scientifically rational response to queries by regulatory agencies.
- Strategic advice to senior management throughout on regulatory requirements.
- Online application submission at NSWS portal
Technical Data Associate
CDSCO
Delhi
09.2011 - 06.2019
- Reviewed CMC, non-clinical & clinical data, TL and protocol amendment application pertain to Global clinical trial (GCT) as per regulatory requirement.
- Reviewed SAE, assisted independent ethics committee of subject expert for causality assessment.
- Reviewed applications pertain to registration of pharmaceutical product and premises, test licence, medical device (IVD) and Ethics Committee Registration.
- Coordination and Data compilation for SEC and technical committee.
- Part of Team for drafting and finalization of General Statutory Rules (GSR) for the Amendment of Drugs and Cosmetics Rule 1940 i.e. New Drugs Clinical Trial Rules 2019, Blood Bank Rules and Cosmetics Rules and Amendment of Rules 96 at Drugs Regulation Section, MoHFW.
- Handled of matter related to department of pharmaceutical, PMO, public grievances, court cases and other policy related matter i.e Price cap for Orphan drug, Gene therapy and Stem cell therapy.
IPQA Chemist
Ankur Drugs & Pharma
Baddi
10.2010 - 08.2011
- IPQA during manufacturing of tablets, ointment and parenteral dosages forms
Training, F&D
Dr. Morepen Lab
Solan
- Oral solid and liquid dosage formulation development.
Education
M. Pharmacy -
BPUT
Berhampur, Odisha01.2009
B. Pharmacy -
RUHS
Jaipur01.2007
Skills
- Clinical trial applications
- Market authorization
- Registration certification
- Pharmacovigilance practices
- Biological product development
- Regulatory compliance and intelligence
- Cross-functional collaboration
- Data management strategies
- Strong negotiation skills
- Effective communication
- Networking and relationship building
Projects
Academic Project — Formulation & Development, Formulation & Development of “Pseudoephedrine HCl sustained release and Loratadine immediate release bilayer tablets”
Awards
Certificate of excellence “On Time Approval” in FY2019 from Biocon, Certificate of excellence “On Time Approval” in FY22-Q1 Biocon
Training
- Successfully completed training on “Adverse Event Reporting” conducted by Biocon on 18.02.2021
- Successfully completed training on CGMP, GMP and QA procedure conducted by Biocon
- Attended “Indian and European Regulatory and Quality Summit 2019” organized by ARAP and TOPRA on 14.11.2019 and 15.11.2019.
- Attended “2nd world conference on Access to Medical products Achieving the SDGs 2030” organized by WHO and Ministry of Health and Family welfare, Government of India.
- Attended “Seminar and Training at the 6th WHO Inter-regional Seminar for Quality Control Laboratories involved in the WHO pre-qualification” organized by WHO and Indian Pharmacopoeia Commission.
Disclaimer
I hereby declare that the above-mentioned details are true to the best of my knowledge Date: Jun - 2025 Place: New Delhi Vijay Pal Bhati
PERSONAL PROFILE
- Date of Birth : 07th Nov 1981
- Nationality : Indian
- Marital status : Married with two kids
Timeline
Manager
AstraZeneca Private India Limited
12.2024 - Current
Deputy Manager
Biocon Ltd
06.2019 - 12.2024
Technical Data Associate
CDSCO
09.2011 - 06.2019
IPQA Chemist
Ankur Drugs & Pharma
10.2010 - 08.2011
Training, F&D
Dr. Morepen Lab
M. Pharmacy -
BPUT
B. Pharmacy -
RUHS
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