Senior Toxicology Manager (Sr. Executive)

About the role

Sun Pharma is seeking a senior toxicology professional to lead the assessment of chemical hazards and support regulatory submissions for its product portfolio. The role is based in Gurgaon and involves close collaboration with cross‑functional teams to ensure safety and compliance.

Key responsibilities

• Perform genotoxicity hazard assessments of starting materials, intermediates, residual solvents and degradation products using QSAR software in line with ICH M7.
• Determine health‑based exposure limits (OEL and PDE) and conduct risk assessments for process‑related impurities.
• Evaluate safety of excipients, nitrosamine impurities and out‑of‑specification drug products.
• Prepare Safety Data Sheets (SDS) and assess health hazard evaluations (HHE) for OOS findings.
• Compile non‑clinical dossiers (CTD modules) for regulatory submissions.
• Collaborate actively with cross‑functional teams and support additional tasks as directed.

Required profile

• 5–10 years of experience in toxicology, preferably in the pharmaceutical industry.
• Advanced degree (M.Pharm) with specialization in Toxicology or equivalent (M.Sc. Biochemistry/Microbiology/Toxicology, B.V.Sc/M.V.Sc).
• Experience conducting animal toxicology studies such as genotoxicity and repeat‑dose toxicity.

Required skills

• Proficiency with QSAR software for genotoxicity assessment.
• Knowledge of ICH M7 guidelines.
• Ability to determine OEL and PDE values.
• Safety Data Sheet (SDS) preparation.
• Risk assessment of impurities and residual solvents.
• Preparation of CTD non‑clinical dossiers.

What we offer

• Competitive benefits and opportunities for professional growth within a global pharmaceutical company.