- Serve as Subject Matter Expert (SME) for non-clinical studies, ensuring alignment with regulatory standards.
- Conduct detailed reviews of regulatory and published databases to evaluate guidance requirements.
- Define preclinical study scopes according to geographic regulatory needs and identify suitable Contract Research Organizations (CROs).
- Design and monitor in vitro/in vivo toxicity studies for APIs, finished products, intermediates, impurities, and collaborative projects globally.
- Develop innovative animal models to evaluate Pharmacokinetics (PK) and Pharmacodynamics (PD) for various dosage forms.
- Review protocols, data, and reports related to toxicity studies.
- Evaluate in-life and terminal parameter data and assess statistical analyses.
- Provide input for regulatory submissions (e.g., NDA/IND) on toxicity sections.
- Conduct literature reviews and provide safety-related data.
- Perform Toxicological Risk Assessments (TRA) for excipients, intermediates, impurities, and chemicals.
- Derive Acceptable Daily Intake (ADI), Permissible Daily Exposure (PDE), Occupational Exposure Limit (OEL), Margin of Safety (MOS), and Environmental Risk Assessment (ERA) as per standards.
- Address regulatory guidance on nitrosamine impurities, including AI derivation and genotoxicity assays.
- Assess impurity qualifications, focusing on general and genotoxic impurities.
- Proficient in standard software (Microsoft Excel, Word, PowerPoint, GraphPad, Minitab) and laboratory calculations.
- Prepare and review Standard Operating Procedures (SOPs) and facilitate internal audits by the DQA.
Qualifications:
- MVSc (Pharmacology & Toxicology) or MSc/MPharm/PhD (Toxicology) with 8-12 years of experience.
- In-depth knowledge of ADMET, PK/PD, acute & subacute toxicity studies, histopathology, and related software (DEREK, LASA, MULTICASE).
- Experience in rodent/non-rodent toxicology, including general toxicology, histopathology, genetic toxicology, and safety pharmacology.
- Strong understanding of GLP/GXP practices and national/international regulatory guidelines.
- Excellent communication and presentation skills.
- DABT certification and medicinal chemistry knowledge are added advantages.