SACHIN
New Delhi
Overview
4
4
years of professional experience
1
1
Certification
Work History
Senior Research Scientist-I
Fresenius Kabi Oncology Limited
Gurugram
01.2024 - Current
- Obtain approval for new drug products through Regulatory filings for EU and ROW markets.
- Perform post-market compliance, including Product Change Notifications for registered drugs.
- Renew licenses and file PSURs for products in EU and ROW markets.
- Compile and publish regulatory submissions using SDMS, EURS, LORENZ Validator, and eCTD Manager.
- Maintain RA database for products in Kabi Regtrack tool.
- Clarify Regulatory Agencies' queries for parenteral products.
- Interact with local marketing, global RA teams, and internal stakeholders for technical documents review.
Research Scientist
Fresenius Kabi Oncology Limited
Gurugram
06.2022 - 12.2023
- Supported regulatory filings for new drug approvals in EU and ROW markets.
- Assisted with post-market compliance, including Product Change Notifications.
- Handled license renewals and PSUR filings for EU and ROW.
- Compiled and published submissions using SDMS, EURS, LORENZ Validator, and eCTD Manager.
- Responded to Regulatory Agency queries for parenteral products.
- Collaborated with marketing and global RA teams to review technical documents.
Executive-Regulatory Affairs in Dosage Corporate Regulatory Affairs
Jubilant Generics Limited
Greater Noida
01.2022 - 06.2022
- Prepare ANDA dossiers for US and EU markets (OSD) in CTD format and manage product lifecycle for US, EU, and Canada markets.
- File post-marketing variations for US, EU, and Canada markets (for OSD).
- Prepare annual reports for US market products
- Update product labeling for the EU market.
- Coordinate with plants to obtain and review technical documents per regulatory requirements.
- Handle CMC-related queries from health authorities and publish sequences using pharmaREADY.
Research Scientist
Sun Pharmaceutical Industries Ltd.
Gurugram
07.2020 - 03.2021
- Prepare annual reports for US market products.
- Respond to Discipline Review Letters (DRL) and Complete Response Letters (CRL).
- Coordinate with plants for technical document review.
- Prepare initial dossiers for US and EU markets (CTD format).
- Manage product lifecycle across US, EU, AUS, and Canada markets.
- File post-marketing variations and update artworks.
- Handle CMC-related health authority queries.
- Compile newsletters on regulatory updates.
Education
M. Pharm (Pharmaceutical Quality Assurance) -
Jamia Hamdard
New Delhi01-2020
Post Graduation Diploma in Pharmaceutical Regulatory Affairs -
Jamia Hamdard
New Delhi01-2019
B. Pharm - Pharmacy
Jamia Hamdard
New Delhi01-2018
Class 12th -
KGSBV
New Delhi01-2014
Class 10th -
KGSBV
New Delhi01-2012
Skills
- Regulator Submissions
- Proficiency in Microsoft Office
- Written Communication
- Dossier Preparation
- Publishing
- Common technical document (CTD)
- Cross-functional Coordination
- Team Coordination
- Query Resolution
Carrier Objective
To be a part of a dynamic organization where I can fully utilize my skills and make a significant contribution to the success of the employer and at the same time my individual growth.
Summary
With around 3 years of experience in drug regulatory affairs for EU, US, and ROW markets, I have gained a deep understanding of regulatory compliance processes and guidelines. I am skilled in conducting regulatory assessments, managing product lifecycles, and preparing detailed submissions and renewals. My experience enables me to adeptly handle complex regulatory environments and maintain effective communication with regulatory agencies. I am excited about the prospect of transitioning my skills and expertise into the dynamic field of medical device regulatory affairs
Certification
- Diploma in Executive Development Course from Indian Institute of Software Technology
- Industrial Training- Devansh Testing & Research Laboratory Pvt. Ltd.
- EU Medical Device Regulatory Affairs (Medical Device Rules 2017) via Udemy
- US Medical Device Regulatory via Udemy
- General Course on Intellectual Property by WIPO
- Good Clinical Practice by NIDA Clinical Trials Network
- Drug Discovery Authorized by University of California San Diego & offered through Coursera
- Drug Development Authorized by University of California San Diego & offered through Coursera
- Six Sigma Yellow Belt by 6SigmaStudy
Accomplishments
February 27, 2018
Certificate of appreciation for qualifying GPAT examination on Pearl Anniversary Celebrations organized by Jamia Hamdard University, SPER, New Delhi and also awarded 2 years scholarship by AICTE for qualifying GPAT examination.
Languages
Hindi
First Language
English
Proficient (C2)
C2
Poster Presentation
January 7-9, 2019
Presented Poster on “Nanostructured ZnO as Biosensor in detection of Hepa-B surface antigen & in cancer” & also participated as Volunteer in “6th World Congress on Nanomedical Sciences” ISNSCON 2019 Organized by Jamia Hamdard & University of Delhi, New Delhi
September 11- 12, 2019
Presented Poster on “HIV-Associated Neurocognitive Disorders: NeuroAIDS” in IPA Convention 2019 Organized by IPA Delhi State Branch
Seminar/ Conferences
October 9- 10, 2018
National conference on “Pharmacovigilance, Pharmacoeconomics & Outcomes Research” Organized by DIPSAR, New Delhi
September 11, 2018
Workshop on “Intellectual Property” Organized by SPER, Jamia Hamdard, New Delhi
December 11-12, 2023
“DIA-US FDA: ANDA Workshop”, Ahmedabad, Gujarat Sponsored by Fresenius Kabi Oncology Limited, Gurugram, Haryana
Publication- Review Article
Aggarwal, N., Sachin, Nabi, B. et al. Nano-based drug delivery system: a smart alternative towards eradication of viral sanctuaries in management of NeuroAIDS. Drug Deliv. And Transl. Res. (2021). [Impact factor: 4.617 (2020)]
Co-curricular activities
- Participated in various Competitions and Quizzes held by CADUCEUS 2016, Rx 2017 & Rx 2018, Jamia Hamdard, New Delhi.
- Volunteered for Innovate Day 2023 at Fresenius Kabi Oncology Limited, contributing to back-stage management and video editing tasks.
Distinctive Highlights
- GPAT All India Rank: 981
- AIIMS M.Sc (Pharmacology): 5th Rank
- NIPER JEE: 888
Declaration
I hereby declare that all the above statements are true, correct to the best of my knowledge and belief.
Timeline
Senior Research Scientist-I
Fresenius Kabi Oncology Limited
01.2024 - Current
Research Scientist
Fresenius Kabi Oncology Limited
06.2022 - 12.2023
Executive-Regulatory Affairs in Dosage Corporate Regulatory Affairs
Jubilant Generics Limited
01.2022 - 06.2022
Research Scientist
Sun Pharmaceutical Industries Ltd.
07.2020 - 03.2021
M. Pharm (Pharmaceutical Quality Assurance) -
Jamia Hamdard
Post Graduation Diploma in Pharmaceutical Regulatory Affairs -
Jamia Hamdard
B. Pharm - Pharmacy
Jamia Hamdard
Class 12th -
KGSBV
Class 10th -
KGSBV
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