Syngene International, a leading innovation-driven contract research, development, and manufacturing organization (CRDMO), is hiring a Regulatory Toxicologist in Bangalore. This role is ideal for professionals with a passion for regulatory toxicology, safety assessment, and risk evaluation in pharmaceuticals, cosmetics, and consumer products.
At Syngene, safety and quality are core principles, and the Regulatory Toxicologist will play a crucial role in ensuring compliance with global regulatory guidelines such as OECD, ICH, FDA, and ISO standards.
Key Responsibilities
- Conduct literature searches and prepare toxicological assessments for raw materials, ingredients, and APIs used in pharmaceuticals and consumer products.
- Prepare and review Nonclinical Overviews for CTD submissions and dossier filings.
- Create Toxicology Profiles for INCI ingredients and residual chemicals.
- Perform risk assessments and Margin of Safety (MoS) calculations for cosmetic applications.
- Derive Health-Based Exposure Limits (PDE/OEL/DNEL/ADI) for various substances.
- Evaluate efficacy and safety (preclinical and clinical) as per regulatory requirements.
- Prepare Safety Data Sheets (SDS) in compliance with GHS standards.
- Extract, analyze, and collate toxicology data using databases like TOXNET, HSDB, PubMed, and ScienceDirect.
- Assess quality of toxicity studies (systemic, genotoxicity, skin/eye irritation, carcinogenicity, etc.).
- Draft and compile research reports and regulatory dossiers aligned with international guidelines.
Qualifications and Experience
Education:
- M.Sc in Toxicology, Pharmacology, or related Life Sciences
- M.Pharm or M.V.Sc
Experience:
- 1โ3 years in Regulatory Toxicology, Safety Assessment, or related fields.
Key Skills:
- Knowledge of GHS, OECD, ICH, FDA, and ISO guidelines.
- Proficiency in toxicological data interpretation and risk assessment methodologies.
- Strong analytical and scientific writing skills.
Benefits at Syngene
- Opportunity to work in an internationally recognized R&D environment.
- Exposure to cutting-edge research and regulatory science.
- Competitive salary and career development programs.
- Safe, inclusive, and collaborative workplace culture.