Dinesh Kumar Boggarapu
Hyderabad
Summary
Accomplished Senior Specialist with extensive experience at Sandoz Private Ltd, adept in Veeva Vault and regulatory submissions. Proven track record in compiling successful MA dossiers and managing complex data. Excels in cross-functional collaboration and regulatory compliance, ensuring timely submissions and enhancing operational efficiency. Knowledgeable senior specialist with deep expertise the field and offering several years of experience in the field sector. Adept at building and leading teams of specialists in daily operations.
Overview
13
13
years of professional experience
Work History
Senior Specialist
Sandoz private Ltd
09.2021 - Current
- Compilation of Initial MA dossiers for Drug Products for Europe markets through DCP, RUP and National Submissions
- Planning, compilation, submission and tracking of new dossiers, Response phases, End of Procedure phase
- Preparation of Module-1 Documentation for Initial MAA Submissions
- Well versed in handling Information in Regulatory Information Data Management Veeva vault from planning to submission
- Successfully handled the Integration of GB and CH Initial submissions to Europe New Submissions Team
- Supported in migration of data from existing applications to Veeva Vault
- Publishing of Documents using Docubridge and submission of Dossier via CESP
- Applications: Veeva Vault – Expertise in updating information of MAA from planning to approval
- SARA- Document Management System for compilation of documents
- Docubridge- Expertise in publishing Dossier for Europe, ROW and GB, CH markets
- Job Rotation-Labelling (October 2024-present): Undergone Training for day-to-day Labelling activities
- Preparation and compilation of documentation for Originator Updates
- Updation of Labelling documentation via PRAC recommendations and CCDS updates
- Updation of SPC and PIL in-line to originator product Information
- Applications: TVT – Expertise in comparison of documents and generate report
Senior Specialist
GlaxoSmithKline Pharmaceuticals Ltd
06.2019 - 09.2021
- Compilation of Renewal dossiers for Drug Products for EU and ROW Markets
- Experienced in Regulatory Information Data Management applications like Require, Veeva Vault, Documentum, Track wise, Docubridge, OPAL
- Preparation and submission of variation packages
- Compilation of Site Registrations for different countries
- Applications: Veeva Vault – Expertise in compiling documents
Senior Executive
Imed global Limited
02.2016 - 06.2019
- Compilation of Initial MAA dossiers for Drug Products in MRP, DCP and National procedures
- Preparation of response to Health Authority questions for MAA submissions, Variations
- Preparation and submission of variation packages: Type IA, IB, II, Grouping for Europe Submissions
- Preparation of Module-1, 3 documents include labelling as per QRD Template
Regulatory Affairs Associate
Kinapse Limited
04.2014 - 02.2016
- Compilation of dossiers for Drug Products in MRP, DCP and National procedures
- Preparation of Renewal Submission Packages for Europe and ROW Markets
- Compilation of Annual Reports to USFDA for NDA and IND
- Preparation and submission of variation packages: Type IA, IB, II, Grouping for Radio Pharmaceuticals
Regulatory Affairs Executive
ELC group s.r.o
05.2013 - 04.2014
- Designing of Regulatory Strategy: DCP Slot booking, Selection of RMS & CMS’s, Evaluation of fees, Selection of Reference Product for BE (+ERP-European Reference Product) & Country specific requirements
- Compilation of dossiers for oral solid formulations and sterile formulations in MRP, DCP and National procedures
- Preparation and submission of variation packages: Type IA, IB, II, Grouping (& super grouping)
Project Trainee (Global Regulatory Affairs)
Mylan Laboratories
07.2012 - 05.2013
- Worked on Evaluation of Post Approval Life Cycle Management of Variations in US, EU and WHO (Dissertation Work)
Education
B.PHARMACY -
SRM University
SRM College Of Pharmacy01.2011
INTERMEDIATE - Bi.P.C
SKM Memorial Junior College
01.2006
S.S.C -
Keshava Reddy Public School
01.2004
Masters of Science - pharmaceutical Regulatory affairs
Manipal College of Pharmaceutical Sciences
ManipalSkills
- Veeva Vault
- Docubridge
- Data management
- Labelling documentation
- Regulatory submissions
- Document management
- Dossier compilation
- Regulatory compliance
- Team collaboration
- Knowledge sharing
- Cross-functional collaboration
Accomplishments
- Presented a Poster on 'Regulatory Affairs Perspective for Combination Products as per US FDA' held in OMICS Regulatory Conference at Hyderabad.
- Worked on a project 'Trademark infringement Analysis in Pharmaceutical Sector' during Summer Training course conducted at Manipal during 05/2012.
- Cleared 'IELTS' with a band score of 6.0.
- Participated as a volunteer in International Conference in Perspectives in Chemometrics held at S.R.M. University.
Extracurricular Activities
Presented a Poster on 'Regulatory Affairs Perspective for Combination Products as per US FDA' held in OMICS Regulatory Conference at Hyderabad. Worked on a project 'Trademark infringement Analysis in Pharmaceutical Sector' during Summer Training course conducted at Manipal during 05/2012. Cleared 'IELTS' with a band score of 6.0. Participated as a volunteer in International Conference in Perspectives in Chemometrics held at S.R.M. University.
Languages
- English
- Hindi
- Telugu
- Tamil
Personal Information
- Date of Birth: 05/03/89
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Senior Specialist
Sandoz private Ltd
09.2021 - Current
Senior Specialist
GlaxoSmithKline Pharmaceuticals Ltd
06.2019 - 09.2021
Senior Executive
Imed global Limited
02.2016 - 06.2019
Regulatory Affairs Associate
Kinapse Limited
04.2014 - 02.2016
Regulatory Affairs Executive
ELC group s.r.o
05.2013 - 04.2014
Project Trainee (Global Regulatory Affairs)
Mylan Laboratories
07.2012 - 05.2013
B.PHARMACY -
SRM University
INTERMEDIATE - Bi.P.C
SKM Memorial Junior College
S.S.C -
Keshava Reddy Public School
Masters of Science - pharmaceutical Regulatory affairs
Manipal College of Pharmaceutical Sciences
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