Preclinical Specialist

Job DescriptionSME for Non-Clinical studies to adequately address the regulatory requirements of DMF/NDA/ANDA applications for various markets/geographiesPerform detail review of regulatory and published database, evaluate the guidance requirementDefine the scope for preclinical study as per the geographical regulatory requirement, evaluate and identify the appropriate CRODesign 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 marketsDesign Innovative animal models to assess the Pharmacokinetics and Pharmacodynamics of different dosage forms viz.

Oral/Injectable/Derma/InhalationsReview of toxicity study protocols/data/reportsReview the in life and terminal parameter data, evaluate the statistical analysis either performed in house or at CROProviding inputs on toxicity sections in documents for regulatory submissions eg.

NDA/IND.Reviewing literature of drugs and providing data on safety related aspectsProvide 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 standardsAware of expectations of regulatory guidance on handling nitrosamine impurities, categorize / derive AI, conduct EAT and follow –on in vivo genotoxicity assayImpurity 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.

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

Additional InformationMandatory Skills:
Knowledge of ADMET, PK/PD, Acute & Subacute toxicity studies, Gross and histopathology, Software experience viz.

DEREK, LASA, MULTICASE, GLP/GXP practice etcAdditional Information:

Strong interest in toxicology of laboratory animalsExperience in rodent/non rodent toxicology including general toxicology, Histopathology, Genetic toxicology and Safety Pharmacology in Pharma industryGood understanding and adherence of GLP/GXP practicesA strong working knowledge of PK/PD, and ADME is an added advantageBasic understanding of national & international regulatory guidelinesExcellent communication/presentation skills.

DABT is an added advantage.
Medicinal chemistry knowledge shall also be an added advantage

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