Aniket Kaware
Lower Parel, Mumbai
Summary
Master's in pharmacy with 7+ years of experience in Regulatory affairs and Quality assurance. Expertise in regulatory compliance, strategic planning, and Post approval activities. Strong review skills for CMC documents.
Overview
8
8
years of professional experience
Work History
Deputy Manager
Inventia Healthcare Ltd.
Thane, Maharashtra
05.2023 - Current
- Prepared dossiers in eCTD (Pharmaready) and CTD formats, adhering to global standards and market-specific requirements for GCC, ASEAN, and MEA regions
- Successfully managed the planning, coordination, and compilation of post-approval variations while ensuring compliance with country regulations.
- Participated in cross-functional team discussions to ensure timely completion of submission documents
- Consistently met deadlines for preparing and responding to client and MOH queries.
- Communicate with different departments like R and D, FRD, ADL, QA, QC to compile required documents for dossier preparation as well as query responses.
- Communicate with client regarding gap analysis received for dossiers and MOH requirements.
- Managed the tracking system for submitting dossiers to MOH and coordinated post-approval tasks.
Executive-Regulatory Affairs
Stallion Laboratories Pvt. Ltd.
Ahmedabad
06.2022 - 05.2023
- Prepared error-free and timely submission of dossiers for CTD/ACTD/Country Specific for the international market adhering to guidelines.
- To evaluate and respond to any regulatory query, client requirement that may arise from health authority.
- Dossier checking of subordinate in CTD, ACTD, and country specific formats.
- Reviewed technical documents such as Process validation, MFR, Specifications, STP, AMV, PDR, Stability studies and other documents from Site QA/QC/ADL against DMF/Dossier Requirement
- Coordinated with third party for technical documents essential for loan-licensed products preparation
- Applied COPP guidelines to request artwork for registration and commercial purposes while adhering to regulatory requirements.
- Maintained and updated all document statuses, Dossier records, and registration statuses.
- Conducted team training sessions and presentations on a regular basis.
- Market Exposure: ASEAN, LATAM, CIS, AFRICAN & ROW MARKET
Executive-Quality Assurance
Leben Laboratories Pvt. Ltd.
Akola
07.2016 - 06.2022
- Review of MFR, BMR, BPR
- Preparation & review of Process Validation,APQR
- Handling of Change control, Deviation & QMS activity
- Coordinated and reviewed requested documents for RA department's dossier preparation
- Preparation of Dossiers
- To Provide Training of SOP, Incidence, GMP to shop floor officers & workers
- Audit Exposure: WHO GMP, Ethiopia, Kenya, Malawi, Nepal, Zambia, Yemen
Education
Post Graduation Diploma - Drug Regulatory Affairs
GIRA
Pune04-2022
Master In Pharmacy - Pharmaceutics
Amaravati University
08-2017
Bachelor of Pharmacy -
Amaravati University
08-2015
HSC -
Maharashtra State Board of Secondary And Higher Secondary Education
Pune05-2011
SSC -
Maharashtra State Board of Secondary And Higher Secondary Education
Pune06-2009
Skills
- Leadership skills
- Proactive
- Adaptable and flexible
- Quick learner
- Team Work
- Passionate about work
- Sound knowledge of working process in the Production Unit
- Exposure to software's (Pharmaready,Inflow,SAP)
Projects
Design and Evaluation of Sustained Tablets Released Using Melt Granulation.
Acknowledgement
I hereby certify that all the information provided above is true to the best of my knowledge.
Timeline
Deputy Manager
Inventia Healthcare Ltd.
05.2023 - Current
Executive-Regulatory Affairs
Stallion Laboratories Pvt. Ltd.
06.2022 - 05.2023
Executive-Quality Assurance
Leben Laboratories Pvt. Ltd.
07.2016 - 06.2022
Post Graduation Diploma - Drug Regulatory Affairs
GIRA
Master In Pharmacy - Pharmaceutics
Amaravati University
Bachelor of Pharmacy -
Amaravati University
HSC -
Maharashtra State Board of Secondary And Higher Secondary Education
SSC -
Maharashtra State Board of Secondary And Higher Secondary Education
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