Profile Details

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USD 25 /hr

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Hire Krishnakant S.

India

USD 25 /hr

Regulatory Toxicologist | Specializing in Toxicological Hazard Assessment, Risk Evaluation, and Regulatory Compliance

Profile Summary

Regulatory Affairs and Toxicology Expertise: 1. Proficient in toxicological hazard assessment and human risk evaluation for product safety across industries. 2. Well-versed in international standards like ISO, FDA, EU MDR, and OECD guidelines, ensuring regulatory compliance and safety assessments. 3. Hands-on experience with toxicological study design, protocol development, and monitoring of laboratory-based studies. 4. Expertise in IUCLID, QSAR Toolbox, and other risk assessment models for regulatory submissions and data analysis. Communication and Project Management: 1. Strong oral and written communication skills for client interactions, presentations, and reporting. 2. Proven track record of time management and the ability to juggle multiple projects without sacrificing quality. 3. Skilled in Microsoft Office tools (Word, Excel, PowerPoint) for data management, report generation, and presentation. Risk Assessments and Database Searches: 1. Conducted comprehensive literature reviews and data mining through platforms like ECHA, PubMed, Web of Science, OVID and many other search engines to evaluate chemical safety. 2. Proficient in risk assessment tools, including GHS, CLP Classification Guidelines, QSAR, Cons Expo Models, and more, to ensure comprehensive human risk assessments.

Subject Matter Expertise

• ☆ Drug Development
• ☆ In vivo Preclinical Toxicology
• ☆ Medical Devices
• ☆ European Medical Device Regulation (MDR)
• ☆ Medical Toxicology
• ☆ Health Risk Assessments
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews

Services

• Writing
• Research
• Consulting
• Data & AI

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Creative Writing, Newswriting

Research Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Data Mining, Data Cleaning, Data Processing, Data Insights

Work Experience

Senior Scientific Officer - Regulatory and Toxicology

Auxilife Scientific Services Pvt Ltd

August 2022 - Present

Education

Masters in Pharmacy (Pharmacology)

Birla Institute of Technology and Science

August 2020 - July 2022

Certifications

• Certification details not provided.