Preclinical Specialist

2 weeks ago

Delhi, Delhi, India Dr. Reddy's Laboratories Full time
Job Description

  • 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.
Qualifications

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

Additional Information

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

  • Preclinical Specialist

    2 weeks ago

    Delhi, Delhi, India Dr. Reddy's Laboratories Full time

    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...