PANKAJ BHADURIYA
Regulatory Affairs Specialist
Greater Noida
Summary
Dynamic Regulatory Affairs Specialist with strong skill in regulatory application data management. Proven ability to collaborate with cross-functional teams, ensuring compliance and timely submissions for markets including the US and Europe. Committed to leveraging regulatory knowledge for impactful product approvals.
- Preparation of Dossiers in eCTD for submission to the respective Agencies of the USFDA, EU and Canada.
- Submission of CMC Documents (Module 1, 2, and 3 for US, EU & Canada)
- Submission of post-approval changes (viz. PAS, CBE-0, CBE-30, Annual report and EU Variations)
Overview
2
2
Languages
13
13
years of professional experience
Work History
Regulatory Affairs Specialist
Felix Pharmaceuticals Pvt. Ltd.
01.2024 - Current
- Compiled and assessed dossiers for PAS and CBE 30 filings in US market, ensuring compliance with regulatory requirements.
- Dossier compilation, evaluation, and submission for the Canada market.
- Prepared responses to queries and deficiencies from regulatory agencies, facilitating timely resolution and approval processes.
- Evaluated technical documents for products in development and commercialization, supporting regulatory submissions and compliance.
- Collaborated with cross-functional teams to ensure timely product approvals.
- Maintained up-to-date knowledge of regulatory changes impacting pharmaceutical products.
Regulatory Affairs Specialist
Centrient Pharmaceuticals
07.2022 - 11.2023
- Preparation, review, and submission of dossiers for regions like the US, Europe, and various emerging markets in eCTD, CTD, or country-specific formats.
- Preparation of regulatory product lifecycle submissions encompassing query responses, variations, annual reports, expedited case reports, renewals, and sunset clause applications.
- Regulatory evaluation and interventions related to quality and artwork change procedures and deviations as indicated by executed QMS.
Regulatory Affairs Specialist
Macleods Pharmaceutical Ltd.
06.2021 - 06.2022
- Coordinate preparation and submission of registration dossier query responses, renewal application, and variation application in alignment with pre-defined timeframe for the European market.
- Coordination and follow-up with respective EU authorities for facilitating outcomes of submitted application NP/DCP slot and recommendations from the agency.
- Engagement with different departments such as PDR, ARD, and business for regulatory strategy.
Regulatory Affairs Manager
Sun Pharmaceutical Industries Ltd.
03.2020 - 06.2021
- To secure conformity with commitments to regulatory bodies and stakeholders.
- Sharing of approval documentation/license relevant to plant and assistance in successful execution of post-approval modifications.
- To ensure regulatory compliance and approval of documents like SOP,APR, FO/MI, PO/PI, Artwork, PM/FP/RM/API specifications, Stability protocol, Validation protocol, report, Investigation protocol and report, and Material code transfer.
Regulatory Affairs Associate
Ipca Laboratories Ltd
03.2014 - 02.2020
- Preparation and assessment of dossier documents like BMR, BPR, formula, COAs, residual solvent statements, dissolution profiling, etc.
Education
PGDRA: Regulatory Affairs - Formulation
Institute of Pharmaceutical Management
Mumbai, India12.2021
Bachelor of Pharmacy - Pharmaceutical Sciences
NRI Institute of Pharmaceutical Science
Bhopal, India06.2010
Higher Secondary - Biological Sciences
Sindhu School
Satna, India06.2003
High School - Science
Sindhu School
Satna, India06.2001
Skills
Regulatory submissions
Regulatory compliance
Regulatory strategy
Regulatory application knowledge
Regulatory data management
eCTD software expertise
Timeline
Regulatory Affairs Specialist
Felix Pharmaceuticals Pvt. Ltd.
01.2024 - Current
Regulatory Affairs Specialist
Centrient Pharmaceuticals
07.2022 - 11.2023
Regulatory Affairs Specialist
Macleods Pharmaceutical Ltd.
06.2021 - 06.2022
Regulatory Affairs Manager
Sun Pharmaceutical Industries Ltd.
03.2020 - 06.2021
Regulatory Affairs Associate
Ipca Laboratories Ltd
03.2014 - 02.2020
PGDRA: Regulatory Affairs - Formulation
Institute of Pharmaceutical Management
Bachelor of Pharmacy - Pharmaceutical Sciences
NRI Institute of Pharmaceutical Science
Higher Secondary - Biological Sciences
Sindhu School
High School - Science
Sindhu School