Prashant Jain
Pune
Summary
Results-driven technical regulatory professional with extensive experience, excelling in compliance documentation and cross-functional collaboration. Proven expertise in CRS projects, analytical method validation and project management, ensuring adherence to ICH and FDA standards. Skilled in stakeholder communication and technical writing, delivering high-quality submissions that meet stringent regulatory requirements.
Overview
13
13
years of professional experience
Work History
Associate II Reg. Submission
Fortrea Ltd., Pune
Pune
08.2020 - Current
- Compiled and reviewed regulatory, quality, and CMC documents to support procedural requirements for clinical release and stability.
- Provided technical expertise for product development by liaising with stakeholders.
- Developed documents for submission to US, EU, ROW, ensuring compliance with regulatory authorities.
- Executed validation and development activities, including report drafting and protocol updates per ICH and FDA guidelines.
- Drafted and reviewed CTA-IND, NDA-MAA, product registration documents, and clinical stability reports.
- Utilized electronic document management systems like eLIMS, TruVault, Veeva Vault etc.
- Coordinated proactively with stakeholders to meet client timelines adhering to regulatory requirements.
- Functions as regulatory subject matter expert regarding diverse components of stability reports, offering strategic insights for submissions to regulatory authorities.
Research Executive (Validation)
SAI Life Sciences Pvt. Ltd
Pune
07.2016 - 04.2020
- Executed AMV, verification and AMT for drug substances and drug products.
- Executed maintenance, calibration, and qualification of all analytical instruments.
- Adherence to SOPs, GCP, and GLP quality systems in compliance with global regulatory standards.
- Delivered quality support and actively drove process solutions addressing incidents, errors, deviation, change control & CAPA.
Senior Research Associate
CENTAUR Pharma Pvt
Pune
06.2015 - 07.2016
- Conducted analytical method validation and facilitated development of analytical testing procedures for drug substances and drug products.
- Felicited exposure to all analytical instruments for analysis of routine samples and stability samples.
Senior Research Associate
IPCA Labs Ltd
Mumbai
02.2015 - 06.2015
- Conducted analytical method development utilizing dissolution and HPLC analysis for API and licensed products
Research Chemist
TCG Lifesciences ltd
Pune
10.2012 - 02.2015
- Executed analytical method development and validation for diverse projects. Analyzed impurities and profiled samples, including preparative fractions, using HPLC and UPLC. Utilized reverse phase chromatography for preparation and analysis of final samples.
QC/QA Analyst
CENTAUR Pharma Pvt. Ltd
Pune
11.2011 - 10.2012
- Conducted analysis of raw material and in-process samples to support manufacturing operations.
- Reviewed and finalized TDS, specifications, BMR, BPR, SOPs to confirm compliance with company SOPs, FDA, GLP, CGMP regulations
Education
Master of Pharmacy - Pharmacognosy And Phytochemistry
Amrutvahini College of Pharmacy
Samgamner10-2011
Bachelor of Pharmacy - Pharmaceutical Sciences
Government College of Pharmacy
Amravati06-2009
Diploma in Pharmacy - Pharmaceutical Sciences
Smt. S .S Patil Institute of Technology
MSBTE06-2006
Skills
- Regulatory compliance & Documentation
- Project management
- Cross-functional collaboration
- Analytical and critical thinking
- Multitasking Abilities
- Stakeholder communication
- Technical writing
- Data analysis
Affiliations
- Proficient in computer software’s (Word, excels & outlook)
- Independent as well as Team Key Player
- Problem Solving with Decision making Skills
- Prompt initiatives and proactiveness
Languages
English
First Language
Hindi
Proficient (C2)
C2
Marathi
Proficient (C2)
C2
Accomplishments
- Year 2011: Awardee as Silver Medalist and Certificate from Amrutvahini college of Pharmacy, Sangamner for second topper in Master of Pharmacy course.
- Year 2009: Awardee as Gold Medalist from Sant Gadge baba Amravati University, Amravati for Throughout Bachelor of Pharmacy University Topper.
- Year 2009: Awardee as Medalist from Government College of Pharmacy, Amravati for Highest marks in Final Year Bachelor of Pharmacy.
- Year 2006: Awardee from Jalgaon District Medical association, Jalgaon for Institute Topper in Diploma in Pharmacy.
References
References available upon request.
Timeline
Associate II Reg. Submission
Fortrea Ltd., Pune
08.2020 - Current
Research Executive (Validation)
SAI Life Sciences Pvt. Ltd
07.2016 - 04.2020
Senior Research Associate
CENTAUR Pharma Pvt
06.2015 - 07.2016
Senior Research Associate
IPCA Labs Ltd
02.2015 - 06.2015
Research Chemist
TCG Lifesciences ltd
10.2012 - 02.2015
QC/QA Analyst
CENTAUR Pharma Pvt. Ltd
11.2011 - 10.2012
Master of Pharmacy - Pharmacognosy And Phytochemistry
Amrutvahini College of Pharmacy
Bachelor of Pharmacy - Pharmaceutical Sciences
Government College of Pharmacy
Diploma in Pharmacy - Pharmaceutical Sciences
Smt. S .S Patil Institute of Technology
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