Sharvari Abhishek Kadam
Navi Mumbai,India
Summary
To pursue a challenging and progressive career in Drug Regulatory Affairs and become a part of organization where I can use my skills, understanding and experience in bringing out the best results and contribute to the growth of the organization.
Overview
11
11
years of professional experience
Work history
Executive- Regulatory Affairs
Lupin Limited
2021.05 - 2025.11
- Responsible for submissions and Lifecycle Management - Europe/UK/US/Canada/WHO and Australia market.
- Ensuring that domestic and international regulatory submissions (e.g., Technical Files, Design DMFs for different markets in different formats (NeeS/ eCTD etc.) are prepared and submitted accurately, completely and in a timely manner to meet and maintain business objectives.
- Submissions of USDMF, EU-ASMF, CEP, WHO, TGA and Health Canada query responses to the respective regulatory authorities through electronic submissions. (ESG, CESP submissions).
- Knowledge and experience in preparation & reviewing of Module 1 to Module 3 CMC Documentation. Compiling eCTD sequences through Educe.
- CMC (Module 3) review which includes reviewing General properties, Manufacturing related documents (batch records, raw materials specification, in-process/intermediate specifications, process validation, development report from R & D), Characterization data, Impurity details, Specifications, Analytical validations data, Batch analysis, stability data etc.
- Performing assessment of: Complete DMF during registration (Drug Development Report, Process Validation, Stability, Batch Analysis, Analytical Method & Validation, BPR, BMR, Certificates of analysis, Container closure system etc.), Query replies and related documents, DMF amendment and related documents and Annual reports and related documents
- Technical data packages / secondary DMFs of intermediates and / or for starting materials.
- Submission of US-Amendments/ASMF Updates / CEP Revisions adequately based on changes proposed for the drug Substances ( for process optimization / recent Pharmacopoeial compliance etc., Annual Reports)
- Prepared and compiled DMF / Technical Packages & Dossiers for submission to the Regulatory Agencies of the various countries (US, Europe, WHO, Canada, Australia & ROW)
- Interact with various departments/teams for regulatory documents and compilation on time as per regulatory requirements.
- Maintenance of the complete history of each drug substance (Filing history with agencies/customers, deficiency responses, amendments, annual reports)
- Issue Letter of Access and other relevant regulatory documents and their submission to regulatory authorities.
Chemist Technical Analyst
Sheekharr Starch Solution Pvt. Ltd.
2018.03 - 2021.04
- Undertaken project related to synthesis of chemically modified starches with its analysis. I have hands on experience on UV Spectrophotometer, GC.
Project assistant
DST-SERB
Matunga
2015.02 - 2018.03
- Development of Synthetic Methodology for the Construction of Libraries of Constrained Analogues of Bioactive Molecules under the Principal Investigator, Dr. Priti Khedkar at G. N. Khalsa College of Arts, Science & Commerce, Matunga.
- The objective of the project was to prepare diversely functionalized biologically active & medicinally important quinolones & coumarins derivatives via the strategic utilization of various metathetic processes such as Suzuki-Miyaura (SM) cross- coupling reaction, Ring Closing metathesis (RCM) reaction, Pechmenn Condensation, Knoevenagel condensation, Allylation reactions, Reduction reactions as per key step. Followed with purification techniques such as column chromatography, preparative TLC.
Education
Post-graduation diploma - Regulatory Affairs (API and Formulation)
Institute of Pharmaceutical Management (IPM)
MumbaiM.Sc. - Organic Chemistry
D.G Ruparel College
MumbaiB.Sc. - Chemistry
C. H. M. College
Ulhasnagar, MumbaiH.S.C - undefined
S.S.C - undefined
Skills
- Regulatory strategies
- CMC submission and documentation review
- Regulatory risks assessment
- Mitigation strategies
- Scientific information review
- ESG & CESP Electronic Submissions
- Regulatory Lifecycle Management
- Innovative problem-solving
- Stakeholder communication
- Multi-priority handling
- Leadership skills
- Interpersonal skills
- Regulatory inputs
- Change proposal evaluation
Languages
English
Hindi
Marathi
Custom Section
Sharvari A. Kadam
Personal Information
- Date of birth: 14th April 1992
- Nationality: Indian
- Marital status: Married
Personal data processing
I hereby declare that above details and information are true to the best of my knowledge.
Timeline
Executive- Regulatory Affairs
Lupin Limited
2021.05 - 2025.11
Chemist Technical Analyst
Sheekharr Starch Solution Pvt. Ltd.
2018.03 - 2021.04
Project assistant
DST-SERB
2015.02 - 2018.03
Post-graduation diploma - Regulatory Affairs (API and Formulation)
Institute of Pharmaceutical Management (IPM)
M.Sc. - Organic Chemistry
D.G Ruparel College
B.Sc. - Chemistry
C. H. M. College