Monika Dubey
Bellevue,WA
Summary
Regulatory Affairs professional with 4+ years of experience in preparation and submission of drug registration dossiers for cosmetics and pharmaceuticals, with comprehensive knowledge of CDSCO applications and ICH guidelines. Demonstrated proficiency in managing complex documentation and responding to regulatory inquiries, ensuring compliance with global standards.
Overview
4
4
years of professional experience
Work History
REGULATORY AFFAIRS
Lambda Therapeutics Research Ltd
New Delhi, India
10.2016 - 02.2018
- Review and submission of dossiers related to BE/CT NOC, T-license etc. to Indian Drug Regulatory Authorities (DCGI), etc.
- Pre-screening and Technical discussions, query response at filing, follow-ups for ongoing projects with the DCGI.
- Uploaded e-CTD dossier on SUGAM portal, ensuring compliance with regulatory standards.
- Timely reporting of SAEs, notifications/amendments regarding deviation in BE/CT studies.
- Maintained project tracking records to support timely completion of projects.
- Managed bank-related tasks, including TR6 Challan preparation for DCGI filing.
Regulatory Affairs Executive
Satyam Consultancy (Drugs and Food)
New Delhi, India
02.2014 - 10.2016
- Compilation of New Drug Application (NDA).
- DMF application for Indian Market.
- Review the Technical quality documents like DMF and PMF.
- Responses to regulatory agencies regarding product information and issue.
- Registration & Import of Blood products, Medical devices, Drugs and Cosmetics on SUGAM portal.
- Addressed inquiries from regulatory agencies about product information and issues.
- Knowledge of GMP guidelines and SOP.
Education
Master of Pharmaceutics -
RGTU
Bhopal, India01-2012
Bachelor of Pharmacy -
RGTU
Bhopal, India01-2010
Skills
- e-CTD submission
- New drug application
- Drug registration preparation
- Clinical trial regulations
- ICH guidelines knowledge(CTD Module1-5)
- Regulatory compliance
- Global regulatory knowledge
- Document management
- SUGAM Portal Submissions
- Medical Device and Cosmetics Registration
Timeline
REGULATORY AFFAIRS
Lambda Therapeutics Research Ltd
10.2016 - 02.2018
Regulatory Affairs Executive
Satyam Consultancy (Drugs and Food)
02.2014 - 10.2016
Master of Pharmaceutics -
RGTU
Bachelor of Pharmacy -
RGTU