Join Syngene as a Regulatory Toxicologist – Apply Now!

🌍 About Syngene International

Syngene International is a leading innovation-driven CRDMO that partners with global pharmaceutical, biotechnology, and consumer product companies. With a strong focus on quality, safety, and compliance, Syngene enables breakthrough scientific discoveries through advanced research and technology platforms.

💼 Position Overview

Role: Regulatory Toxicologist
Location: Bangalore, India
Employment Type: Full-time | On-site
Department: Regulatory Toxicology

The role involves conducting regulatory safety assessments, preparing toxicology reports, and ensuring compliance with global regulatory standards including OECD, ICH, FDA, and ISO.

🧾 Key Responsibilities

• Conduct literature reviews and prepare toxicological risk assessments for raw materials, ingredients, and APIs.

• Prepare and review Nonclinical Overviews for CTD submissions and global dossier filings.

• Develop Toxicology Profiles for INCI ingredients and residual chemicals.

• Perform risk assessments and Margin of Safety (MoS) evaluations for cosmetic and consumer applications.

• Derive Health-Based Exposure Limits (PDE/OEL/DNEL/ADI) for diverse substances.

• Review preclinical and clinical safety data to ensure regulatory compliance.

• Prepare Safety Data Sheets (SDS) following GHS guidelines.

• Retrieve, analyze, and interpret toxicological data from databases like TOXNET, HSDB, PubMed, and ScienceDirect.

• Evaluate the quality of studies involving systemic toxicity, genotoxicity, carcinogenicity, and irritation endpoints.

• Draft and compile regulatory toxicology dossiers, summaries, and technical reports.

🎓 Qualifications and Experience

Education:

• M.Sc in Toxicology, Pharmacology, or related Life Sciences

• M.Pharm or M.V.Sc

Experience:

• 1–3 years of experience in Regulatory Toxicology, Safety Assessment, or Risk Evaluation

Core Skills:

• Comprehensive understanding of OECD, ICH, FDA, ISO, and GHS regulatory frameworks

• Strong expertise in toxicological data interpretation and health risk assessment

• Proficiency in scientific writing, documentation, and data management

• Attention to detail with strong analytical and problem-solving abilities

🌟 Why Join Syngene?

• Work with one of India’s most respected global research organizations.

• Exposure to cutting-edge regulatory science and safety research.

• Competitive compensation and benefits aligned with global standards.

• Professional growth through training and international collaboration.

• Safe, inclusive, and innovation-driven workplace culture.

📩 How to Apply

Interested candidates can apply through Syngene’s official career portal or send their updated resume to careers@syngeneintl.com with the subject line:
“Application for Regulatory Toxicologist – Bangalore.”