Nirmal Bhangale
Jalgaon
Summary
Dedicated Regulatory Affairs & Quality Documentation Specialist with hands-on experience in preparing and reviewing CTD, ACTD, and nutraceutical dossiers for global regulatory agencies. Proficient in artwork development, secondary packaging review, and product insert creation for pharmaceuticals products. Possesses a strong working knowledge of global regulatory submission requirements with a track record of coordinating filings in markets such as Zambia, Mauritius, and Cambodia. Proven ability to collaborate with cross-functional teams and third-party manufacturers to meet regulatory timelines and compliance expectations.
Overview
2
2
years of professional experience
2
2
Certifications
Work History
Regulatory Affairs – Quality Documents Specialist
Viesaine Pharma Pvt. Ltd.
Pune
06.2025 - Current
- Prepared and compiled CTD dossiers for Zambia, Mauritius, and African regulatory authorities.
- Developed ACTD dossiers for Cambodia and Laos in compliance with regional guidelines.
- Managed renewal dossiers for nutraceutical products across multiple international markets.
- Reviewed and updated packaging artwork and product inserts for pharmaceuticals and dermatology registrations.
- Performed dossier reviews to ensure accuracy, consistency, and regulatory compliance prior to submission.
- Coordinated with third-party manufacturers to obtain and review technical, quality, and packaging documentation required for regulatory submissions.
- Followed standardized processes for dossier preparation across jurisdictions.
QA Intern
Sanofi
Goa
05.2024 - 05.2025
- Conducted thorough reviews and ensured compliance for executed batch records and logbooks.
- Performed product quality reviews and analyzed CAPVER data for annual product quality reviews (APQR).
- Coordinated cGMP training activities, including module reviews and staff training sessions.
- Issued controlled copies and edited master forms within Veeva Vault for accuracy.
- Executed line clearances in production and packing, including conducting in-process checks.
- Oversaw sampling during routine and validation batches while ensuring quality on the shop floor.
- Supported deviation investigations and market complaint resolutions, focusing on root cause analysis and CAPA implementation.
Education
Master of Pharmacy - Quality Assurance
Smt. Kashibai Navale College of Pharmacy
Pune08-2024
Bachelor of Pharmacy - Pharmacy
Sinhgad College of Pharmacy,Vadgaon
Pune06-2021
High School Diploma -
Diploma of Pharmacy, Faizpur
Jalgaon06-2019
Skills
- Regulatory compliance
- Dossier preparation
- Quality assurance
- Technical documentation
- Product registration
- Process optimization
Languages
English
Advanced (C1)
C1
Hindi
Advanced (C1)
C1
Marathi
Advanced (C1)
C1
Certification
• Certified Risk Assessment Expert: ISO 31000 (Udemy)
Timeline
Regulatory Affairs – Quality Documents Specialist
Viesaine Pharma Pvt. Ltd.
06.2025 - Current
QA Intern
Sanofi
05.2024 - 05.2025
Master of Pharmacy - Quality Assurance
Smt. Kashibai Navale College of Pharmacy
Bachelor of Pharmacy - Pharmacy
Sinhgad College of Pharmacy,Vadgaon
High School Diploma -
Diploma of Pharmacy, Faizpur