As a Preclinical Specialist at Dr. Reddy’s Laboratories, you will serve as the Subject Matter Expert (SME) for Non-Clinical studies, ensuring compliance with regulatory requirements for DMF/NDA/ANDA applications across various markets and geographies. Your responsibilities will include:
- Conducting detailed reviews of regulatory and published databases to evaluate guidance requirements.
- Defining the scope for preclinical studies according to geographical regulatory needs and identifying appropriate CROs.
- Designing and overseeing the conduct of in vitro/in vivo toxicity studies for API and Finished products, intermediates, impurities, and collaborative projects.
- Developing innovative animal models to assess Pharmacokinetics and Pharmacodynamics of different dosage forms.
- Reviewing toxicity study protocols, data, and reports.
- Providing inputs on toxicity sections in regulatory submissions such as NDA/IND.
- Reviewing drug literature and providing safety-related data.
- Conducting Toxicological Risk assessments of various substances to support generic drug manufacture, development, and marketing.
- Deriving regulatory standards such as ADI / PDE / OEL / MOS/ERA.
- Handling nitrosamine impurities, categorizing AI, conducting EAT, and follow-on in vivo genotoxicity assays.
- Assessing impurity qualifications for general & genotoxic impurities.
- Proficiency in standard software and laboratory calculations.
- Preparation and/or review of functional SOPs and facilitating internal audits.
Qualifications:
- 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.
- Strong interest in laboratory animal toxicology.
- Experience in rodent/non-rodent toxicology, including general toxicology, Histopathology, Genetic toxicology, and Safety Pharmacology in the Pharma industry.
- Good understanding and adherence to GLP/GXP practices.
- Strong working knowledge of PK/PD, and ADME.
- Basic understanding of national & international regulatory guidelines.
- Excellent communication/presentation skills.
- DABT certification is an added advantage.
- Medicinal chemistry knowledge is also an added advantage.
Additional Information:
- Strong interest in laboratory animal toxicology.
- Experience in rodent/non-rodent toxicology, including general toxicology, Histopathology, Genetic toxicology, and Safety Pharmacology in the Pharma industry.
- Good understanding and adherence to GLP/GXP practices.
- Strong working knowledge of PK/PD, and ADME.
- Basic understanding of national & international regulatory guidelines.
- Excellent communication/presentation skills.
- DABT certification is an added advantage.
- Medicinal chemistry knowledge is also an added advantage