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Rahul Mishra
Regulatory Affairs Specialist
Regulatory Affairs Specialist
Rahul Mishra is a Regulatory Affairs Specialist with over 12 years of experience in global drug product registrations and lifecycle management across Europe/UK, Latin America, ASEAN, CIS, and African markets. He has strong expertise in CMC documentation, CTD/eCTD dossier preparation, regulatory publishing, and post-approval submissions. Skilled in interpreting and applying international regulatory guidelines (ICH, EMA), Rahul collaborates closely with cross-functional teams to ensure compliance and timely approvals. Known for providing regulatory strategy, leading submission planning, and resolving health authority queries efficiently, he drives smooth regulatory operations and supports successful product commercialization in global markets
FORMERLY AT
Fresenius Kabi India Pvt. Ltd.
LOCATION
Gurugram
AVAILABILITY
Full-time
Skills
Analytical Documentation Tools
CMC Documentation
Compliance Tracking Tools
CTD/ACTD/NeeS Dossier Formats
eCTD Manager (Extedo)
ICH/EMA Guidelines
MHRA Portal
PharmaREADY
QA/QC Coordination Systems
QC Lab Systems
Regulatory Submission Portals
Work Experience
Regulatory Associate (Europe/UK)
Fresenius Kabi India Pvt. Ltd
November 2023 – Present
- Preparation and review of regulatory submissions for CP, MRP, DCP, National, and IRP procedures.
- Manage MA applications and lifecycle updates via MHRA portal.
- Draft and review Modules 1 & 3 ensuring adherence to ICH/EMA guidelines.
- Provide regulatory strategy, coordinate responses to health authority queries, and serve as SME for eCTD publishing systems.
TECHNOLOGIES
eCTD Manager (Extedo), MHRA Portal, ICH/EMA Guidelines, CMC Documentation
Executive – Regulatory Affairs
Ajanta Pharma Ltd
August 2017 – October 2023
- Compiled, reviewed, and dispatched CTD, ACTD, and NeeS dossiers for Latin America and ASEAN regions.
- Prepared scientific justifications and deficiency responses.
- Managed variation filings, lifecycle submissions, and eCTD compilations.
- Coordinated documentation with QA, QC, R&D, and Production departments.
TECHNOLOGIES
PharmaREADY, CTD/ACTD/NeeS Dossier Formats, Regulatory Submission Portals
Executive – Regulatory Affairs
Sunrise International Labs Ltd
September 2016 – August 2017
- Supported preparation of country-specific regulatory submissions.
- Coordinated technical document collection and ensured accuracy across cross-functional teams.
- Managed regulatory documents and archival.
TECHNOLOGIES
CTD/ACTD Dossier Structuring, QA/QC Coordination Systems
Senior Officer – Regulatory Affairs
Akums Drugs & Pharmaceuticals Ltd.
August 2014 – August 2016
- Prepared regulatory documentation for ROW markets and maintained submission records.
- Oversaw license management and ensured regulatory compliance for product registrations.
TECHNOLOGIES
Regulatory Documentation Systems, Compliance Tracking Tools
