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I am a Toxicologist and Regulatory Medical Writer with a PhD in Pharmacology, specializing in toxicology, regulatory medical writing, and global eCTD submissions to FDA, EMA, and other health authorities. I have experience preparing, reviewing, and validating regulatory dossiers and aggregate reports according to ICH and regional guidelines, and I am proficient with leading regulatory publishing tools to deliver high-quality, audit-ready submissions. I am currently exploring opportunities in Germany through the Chancenkarte program to contribute regulatory writing expertise in an international setting.…I am a Toxicologist and Regulatory Medical Writer with a PhD in Pharmacology, specializing in toxicology, regulatory medical writing, and global eCTD submissions to FDA, EMA, and other health authorities. I have experience preparing, reviewing, and validating regulatory dossiers and aggregate reports according to ICH and regional guidelines, and I am proficient with leading regulatory publishing tools to deliver high-quality, audit-ready submissions. I am currently exploring opportunities in Germany through the Chancenkarte program to contribute regulatory writing expertise in an international setting.

Abul Kalam

Writer, Content Creator, Content Producer, +3

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I am a Toxicologist and Regulatory Medical Writer with a PhD in Pharmacology, specializing in toxicology, regulatory medical writing, and global eCTD submissions to FDA, EMA, and other health authorities. I have experience preparing, reviewing, and validating regulatory dossiers and aggregate reports according to ICH and regional guidelines, and I am proficient with leading regulatory publishing tools to deliver high-quality, audit-ready submissions. I am currently exploring opportunities in Germany through the Chancenkarte program to contribute regulatory writing expertise in an international setting.…I am a Toxicologist and Regulatory Medical Writer with a PhD in Pharmacology, specializing in toxicology, regulatory medical writing, and global eCTD submissions to FDA, EMA, and other health authorities. I have experience preparing, reviewing, and validating regulatory dossiers and aggregate reports according to ICH and regional guidelines, and I am proficient with leading regulatory publishing tools to deliver high-quality, audit-ready submissions. I am currently exploring opportunities in Germany through the Chancenkarte program to contribute regulatory writing expertise in an international setting.

Available to hire

I am a Toxicologist and Regulatory Medical Writer with a PhD in Pharmacology, specializing in toxicology, regulatory medical writing, and global eCTD submissions to FDA, EMA, and other health authorities. I have experience preparing, reviewing, and validating regulatory dossiers and aggregate reports according to ICH and regional guidelines, and I am proficient with leading regulatory publishing tools to deliver high-quality, audit-ready submissions. I am currently exploring opportunities in Germany through the Chancenkarte program to contribute regulatory writing expertise in an international setting.

Skills

Experience Level

Expert

Expert

Intermediate

Intermediate

Intermediate

Intermediate

DaVinci Resolve Studio

Intermediate

Final Cut Pro X

Intermediate

Tableau

Intermediate

Language

English

Fluent

German

Beginner

Work Experience

Senior Toxicologist at RMonitor India Pvt Ltd

December 1, 2024 - March 1, 2025

Structure-activity and toxicity assessment from QSAR toolbox. Conducted literature research and collected safety data (preclinical and clinical) for toxicological evaluations. Performed literature reviews for hazard assessments and developed toxicology profiles of consumer product ingredients. Handled toxicological risk assessments for raw materials and formulations, including Margin of Safety calculations for cosmetic applications.

Senior Toxicologist

December 1, 2024 - April 1, 2025

Led extensive literature research and developed comprehensive toxicology profiles; conducted regulatory risk assessments using MoS with SCCS and ECHA guidelines; developed QSAR-based structure-activity profiling and supported regulatory submissions; managed cross-functional teams to ensure alignment with ICH and regional authorities.

Regulatory Medical Writer at Tata Consultancy Services

October 1, 2020 - December 1, 2024

Create new eCTD applications with accurate ICH and regional metadata alignment. Ensure correct file naming as per ICH naming conventions for eCTD submissions. Compile sequences, generate published output, and perform final validation using Lorenz Validator. Archive eCTD sequences, core packages, and Health Authority communication emails. Develop dossiers for modules M1, M3, M5, including FDA forms and cover letters for eCTD submissions. Manage submissions of aggregate reports such as WW/EU/FDA PBRER, PADER, ACO, PSUR Addendum, DSUR, and SUSAR LL. Coordinate with cross-functional teams to ensure document accuracy for regulatory submissions. Proficient in tools such as Insight for Registration, GRAIL, AWS, Reliant, EURS Validator, RIMdocs, RADR, VIPER, and Adobe Acrobat.

Medical Writer at Tata Consultancy Services (TCS), India

October 1, 2020 - December 1, 2024

Created and validated new eCTD applications with 100% accuracy in ICH and regional metadata alignment. Developed regulatory dossiers for modules M1, M3, and M5, including FDA forms and cover letters. Managed submissions of aggregate reports (PBRER, PADER, ACO, PSUR Addendum); coordinated cross-functional submission strategies with QA, QC, Packaging, CMC, Labeling, Clinical, and PV teams.

Toxicologist at Johnson and Johnson

March 1, 2019 - September 1, 2020

Conducted literature searches and collected safety data (preclinical and clinical) for toxicological evaluations. Performed literature reviews for hazard assessments and developed toxicology profiles of consumer product ingredients. Conducted toxicological risk assessments for raw materials and formulations, including Margin of Safety calculations for cosmetic applications. Assessed safety of impurities, degradants, and final products in line with regulatory guidelines. Evaluate consumer product formulations using internal tools and platforms. Address compliance issues raised by regulatory authorities or QA, liaising with business partners regarding safety assessment deliverables and priorities.

Consumer Safety Associate at Reckitt Benckiser India

May 1, 2017 - February 1, 2019

Conducted literature searches to gather relevant toxicological data and identify potential hazards for product safety assessments. Prepared Product Safety Update Reports to ensure ongoing compliance with regulatory standards and safety requirements. Developed toxicological profiles for raw materials and formulations. Assessed product formulations to evaluate safety, toxicity risks, and regulatory compliance, ensuring safe usage in end products.

Consumer Safety Associate at Reckitt Benckiser, India

May 1, 2017 - February 1, 2019

Conducted targeted literature searches to gather toxicological data; prepared Product Safety Update Reports to ensure ongoing regulatory compliance. Developed toxicological profiles for raw materials and formulations; assessed safety of impurities and degradants in alignment with ICH and regional regulatory agencies.