Preclinical Specialist

• SME for Non-Clinical studies to adequately address the regulatory requirements of DMF/NDA/ANDA applications for various markets/geographies
• Perform detail review of regulatory and published database, evaluate the guidance requirement
• Define the scope for preclinical study as per the geographical regulatory requirement, evaluate and identify the appropriate CRO
• Design and monitor the conduct of in vitro/in vivo toxicity Studies for all API and Finished products, intermediates, impurities and various collaborative projects for India and other international markets
• Design Innovative animal models to assess the Pharmacokinetics and Pharmacodynamics of different dosage forms viz. Oral/Injectable/Derma/Inhalations
• Review of toxicity study protocols/data/reports
•  Review the in life and terminal parameter data, evaluate the statistical analysis either performed in house or at CRO
• Providing inputs on toxicity sections in documents for regulatory submissions eg. NDA/IND.
• Reviewing literature of drugs and providing data on safety related aspects
• Provide Toxicological Risk assessment (TRA) of excipients/ intermediates/ impurities/ chemicals/ cleaning agents in order to support generic drug manufacture, development and marketing.
• Derive ADI / PDE / OEL / MOS/ERA as per the regulatory standards
• Aware of expectations of regulatory guidance on handling nitrosamine impurities, categorize / derive AI, conduct EAT and follow –on in vivo genotoxicity assay  
• Impurity qualification / assessments for general & genotoxic impurities.
• Proficiency in the use of standard software including Microsoft Excel, Word, Powerpoint, Graphpad, Minitab etc. and with standard laboratory calculations.
• Prepare and/or review the functional SOP's.  Facilitating the internal audits by DQA.

MVSc (Pharmacology & Toxicology) or MSc/ MPharm/PhD (Toxicology) with 8-12 Years of experience

Mandatory Skills:

Knowledge of ADMET, PK/PD, Acute & Subacute toxicity studies, Gross and histopathology, Software experience viz. DEREK, LASA, MULTICASE, GLP/GXP practice etc

Additional Information:

• Strong interest in toxicology of laboratory animals
• Experience in rodent/non rodent toxicology including general toxicology, Histopathology, Genetic toxicology and Safety Pharmacology in Pharma industry
• Good understanding and adherence of   GLP/GXP practices
• A strong working knowledge of PK/PD, and ADME is an added advantage
• Basic understanding of national & international regulatory guidelines
• Excellent communication/presentation skills.
• DABT is an added advantage.
• Medicinal chemistry knowledge shall also be an added advantage