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About Company

Dr. Reddy's Laboratories is seeking a skilled Preclinical Specialist to join our team in Hyderabad, Telangana. This role involves managing non-clinical studies to ensure compliance with regulatory requirements for DMF/NDA/ANDA applications across various markets.

Position Name :

Preclinical Specialist

Organization :

Dr. Reddy's Laboratories


MVSc (Pharmacology & Toxicology) or MSc/MPharm/PhD (Toxicology)


8-12 years of experience.


10 - 17.6 Lakhs per year



  • 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.


  • 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.

Application Link

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