APARESH DAS
South Tripura
Summary
A career that is enriching in terms of inputs which provides ample scope for employing my abilities to achieve constant advancements and to work for the betterment of the organization.
Overview
1
1
Language
8
8
years of professional experience
Work History
Executive (Grade 4) – Global Regulatory Affairs
Apotex GBS
Mumbai
07.2026 - Current
- Responsible for the compilation, review, and submission of CMC sections (Modules 1, 2 and 3) for ANDA, ANDS, NDA, NDS, and 505(b)(2) applications for US and Canada markets, ensuring compliance with Health Authority requirements.
- Provide regulatory strategy and assessment support from the early stages of product development, including drug product selection, reference product evaluation, suitability petition assessment, and regulatory pathway determination.
- Lead preparation and review of regulatory submissions for oral solid dosage forms and sterile injectable products in accordance with USFDA and Health Canada requirements.
- Review and support pre-submission activities including Pre-IND, scientific advice, development meetings, controlled correspondences, general correspondences, and suitability petitions with regulatory agencies.
- Collaborate with cross-functional teams including R&D, Analytical Development, Quality Assurance, Supply Chain, Medical Affairs, and Project Management to support product development and regulatory submissions.
- Evaluate regulatory risks, identify submission requirements, and develop strategies to facilitate successful first-cycle reviews and minimize agency deficiencies.
- Coordinate the compilation, review, and timely submission of deficiency responses, ensuring alignment with agency expectations and approval timelines.
- Support launch readiness activities for approved products by providing regulatory expertise and ensuring fulfilment of post-approval commitments.
- Review technical documents including specifications, analytical method validation reports, process validation reports, stability protocols and reports, batch manufacturing records, change controls, and other CMC documentation required for submissions.
- Maintain regulatory databases and systems including RIMS, DocuBridge, submission trackers, deficiency databases, and quality management systems to ensure accurate project tracking and regulatory compliance.
- Monitor evolving USFDA, Health Canada, and ICH regulatory requirements and integrate regulatory intelligence into development and submission strategies.
- Drive continuous improvement initiatives by developing submission checklists, sharing key regulatory learnings, and implementing best practices to improve submission quality and operational efficiency.
- Represent Global Regulatory Affairs in internal cross-functional forums and effectively engage with internal and external stakeholders, including third-party manufacturers and development partners.
Senior Executive - Regulatory Affairs
Micro Labs Private Limited
Bangalore
09.2021 - 07.2024
- Compilation and preparation of M1, M2 and M3 modules for ANDA submissions, ensuring compliance with USFDA guidelines and eCTD format.
- Spearheaded successful regulatory submissions and obtained approval for various dosage form such as tablets, capsules, modified release tablets, modified release capsules etc. adhering to USFDA regulations and guidelines.
- Collaborated effectively with cross-functional teams, including R&D, QA and QC to address technical challenges raised by the USFDA during the review process, ensuring compliance and optimal outcomes.
- Responsible for reviewing of all approved quality study reports such as PDR, BMR, specifications, analytical method validation, hold time protocols and reports, Stability protocols and reports etc. required for submission.
- Proactively managed workload, timelines and identified priorities, demonstrating excellent organizational skills.
- Ensuring accurate and timely response to queries of the respective regulatory agency.
- End to end interactions with stakeholders and responsible for organizing meetings in synergy with the Project management team for timely submission of dossiers.
- Involved in post-approval life-cycle management activities for the US market.
- Writing controlled correspondences to USFDA.
- Identifying reference products for US market for generic application.
- Working on Pharma-ready software to prepare and upload dossier documents.
- Review of the change controls and knowledge on Trackwise.
Research Associate (E2) - Formulation R&D
Lupin Research Park
Pune
10.2020 - 08.2021
- Development of solid oral dosage form such as tablets, capsules, modified release tablets and modified release capsules for Regulated Market.
- Identification and optimization of suitable process parameters and components for manufacturing the product.
- Involved in patent search and related literature.
- Design and perform stability studies as per ICH guidelines.
- Step wise documentation for formulation development (e.g. stability protocols, compatibility protocols, MFR, BMR, PDR etc.).
- Handling laboratory equipment such as RMG, FBD, Roller Compactor, Multi mill, Tablet Compression machine, Coating machine, Disintegration Tester, Capsule filling machine.
- Demonstrated a broad understanding of the pharmaceutical industry, drug development environment and R&D process and objectives.
Officer - Formulation Scientist
Medreich R&D Center
Bangalore
08.2018 - 09.2020
- Development of solid oral dosage form such as tablets, capsules, modified release tablets, modified release capsules etc. for Regulated Market.
- Identification and optimization of suitable process parameters and components for manufacturing the product.
- Design and perform stability studies as per ICH guidelines.
- Step wise documentation for formulation development (e.g. stability protocols, compatibility protocols, MFR, BMR, PDR etc.).
- Handling laboratory equipment such as RMG, FBD, Roller Compactor, Multi mill, Tablet Compression machine, Coating machine, Disintegration Tester, Capsule filling machine.
Education
M. Pharmacy - Pharmaceutics
JSS College of Pharmacy
Mysuru01-2018
B. Pharmacy -
Regional Institute of Pharmaceutical Science and Technology
01-2016
2nd PUC -
B. K. Institution
01-2012
10th class -
Gabtali High School
01-2010
Skills
- CMC (Module-1, 2 and 3) of ANDA for US and Canada Market
- Regulatory strategy development for ANDA, ANDS, NDA, NDS and 505(b)(2) submissions
- Expertise in suitability petition assessments, regulatory pathway evaluation and reference product selection
- Experience in regulatory correspondence with USFDA and Health Canada
- Regulatory support for oral solid dosage forms and sterile injectable products
- Proficient in regulatory systems including pharmaREADY, DocuBridge, RIMS and eCTD publishing tools
- Stakeholder management and strategic planning for regulatory submissions
- Well Versed in ICH Guidelines quality and knowledge of USFDA guidelines
- Fundamental knowledge on operating systems Windows
- Well Versed with MS Office such as Word, Excel, and Power Point
- Keen observation and proper analysis of the problem
- Ability to work in a team, discipline and punctuality
- Adoptable to job challenges and changes
- Effective listener
Websites, Portfolios, Profiles
https://www.linkedin.com/in/aparesh-das-a823b0149
Personal Details
Languages known : English, Hindi and Bengali
Personal Details
Hobbies : Cooking, Running, Playing badminton
Hobbies and Interests
Hobbies : Cooking, Running, Playing badminton
Project and Industrial training
Title: Development and evaluation of poly-herbal cream for wound healing activity at JSS College of Pharmacy, Mysuru.
Achievements and Extracurricular activities
Received “Star performer” award in recognition of remarkable technical knowledge and timely submissions for US market (Micro Labs Private Limited)., Received “Employee of the Month” award for successful development and approval of OSD formulations (Medreich R&D Center).
Training
Industrial training: At Zydis Healthcare Ltd, Sikkim in 2015 for a period of 1 month.
Declaration
I hereby declare that all the above mentioned information is genuine to the best of my knowledge Date: Place: Bangalore (Mr. Aparesh Das)
Timeline
Executive (Grade 4) – Global Regulatory Affairs
Apotex GBS
07.2026 - Current
Senior Executive - Regulatory Affairs
Micro Labs Private Limited
09.2021 - 07.2024
Research Associate (E2) - Formulation R&D
Lupin Research Park
10.2020 - 08.2021
Officer - Formulation Scientist
Medreich R&D Center
08.2018 - 09.2020
M. Pharmacy - Pharmaceutics
JSS College of Pharmacy
B. Pharmacy -
Regional Institute of Pharmaceutical Science and Technology
2nd PUC -
B. K. Institution
10th class -
Gabtali High School