Nikita Ghatage
Kamothe
Summary
Experienced Regulatory Affairs Officer adept at navigating European regulatory frameworks. Proven expertise in developing and executing regulatory strategies, overseeing submissions, and ensuring EMA compliance. Skilled in managing variations and initial dossier applications, with a comprehensive understanding of quality management, pharmacovigilance, and risk management. Collaborative communicator committed to upholding regulatory standards for successful market access in Europe.
Overview
2
2
years of professional experience
Work History
Jr. Officer - Regulatory Affairs
Macleods Pharmaceuticals Limited
04.2022 - Current
- Preparation, compilation, and submission of dossier, variation, MRDCRP application, line-extension application and renewal application in eCTD format for Europe and UK market.
- Practical experience with tools such as Pharmaready, Trackwise, Lorenz eValidator, DMS, submission portals such as CESP, UK-MHRA, Infarmed (PT-portal), AIFA (IT-Portal) and PharmNet.Bund (DE-Product information).
- Calculated costs for variations and initial dossier applications, ensuring compliance with CMDh requirements and specific fee structures in respective countries.
- Timely review of CMC documents like Specifications, Analytical Method Validation, Certificate of Analysis, Elemental risk assessment report, Batch Manufacturing Record, Batch Packaging Record and Stability Data etc. required for dossier compilation.
- Product life cycle management of registered and commercial products.
- Review of summary of product characteristics, patient information leaflet and commercial artworks of registered product and commercial product launch.
- Led successful interactions with European regulatory authorities, directing approval processes for variations and comprehensive procedures, including the national phase for MA grant.
- Collaborated cross-functionally to compile, review, and submit variations and initial dossier applications, contributing to a streamlined regulatory submission process.
Education
M. Pharmacy - Quality Assurance
Oriental College of Pharmacy
Sanpada, India06.2023
B. Pharmacy -
Shri. D.D. Vispute College of Pharmacy
Panvel, India10.2020
HSC
C.K.T. Junior College of Science, Arts And Commerc
Panvel05.2016
SSC
Mahatma School of Academics And Sports
Panvel, India05.2014
Skills
Collaboration and Communication
Time Management
Problem-Solving
Document Management
academic research project:
- Hydrolysis of some organic compounds by using green catalyst. (B.Pharm). Publication- HYDROLYSIS REACTION OF ORGANIC COMPOUNDS AND SUCROSE CATALYZED BY LEMON JUICE: A GREEN CATALYST in Anvesak A bi-annual journal
- Analytical Method Development and Validation of API in Marketed Formulation by RP- HPLC.
industrial training
- Completed 6 Month training in Analytical Development from 9/08/2021 to 9/02/2022 in Alkem Laboratories Ltd. (Taloja, Panvel)
- Completed 1 Month internship in “Q.A., Q.C & Production” department under qualified officers in cGLP& cGMP from 01/06/2019 to 30/06/2019 from Sanjivani Parenteral Ltd. (Rabale, Navi Mumbai)
Languages
English
Hindi
Marathi
Timeline
Jr. Officer - Regulatory Affairs
Macleods Pharmaceuticals Limited
04.2022 - Current
M. Pharmacy - Quality Assurance
Oriental College of Pharmacy
B. Pharmacy -
Shri. D.D. Vispute College of Pharmacy
HSC
C.K.T. Junior College of Science, Arts And Commerc
SSC
Mahatma School of Academics And Sports
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