Toxicologist

As a Toxicologist / Preclinical Scientist at our organization, you will play a crucial role in conducting toxicological risk assessments and overseeing preclinical experimental research. Your responsibilities will include deriving health-based exposure limits, conducting toxicological risk assessments for various substances, performing genotoxicity hazard assessments, evaluating extractable and leachable impurities, and determining harmful doses for children. In addition, you will be involved in developing preclinical strategies, planning, overseeing, and interpreting in vitro and in vivo preclinical toxicology studies, pharmacokinetics/pharmacodynamics studies, biocompatibility studies for medical devices, and immunogenicity studies for peptides and biosimilar products. You will also be responsible for summarizing toxicological data and preparing regulatory submissions such as Investigational Brochures, Investigational New Drug applications, and electronic Common Technical Document for regulatory authorities. To qualify for this role, you should have an advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Medicine, or a related field, along with a minimum of 3-5 years of experience in toxicological risk assessment and experimental toxicology in the pharmaceutical, CRO, or biotechnology industry. You must possess a strong understanding of regulatory guidelines from organizations such as ICH, USFDA, EMA, CFDA, and DCGI, and have experience with regulatory submissions. Furthermore, you should demonstrate the ability to manage multiple projects simultaneously, work effectively in a dynamic team environment, communicate excellently, collaborate cross-functionally, and interact with external partners such as CROs. Being detail-oriented with proactive planning abilities, strong analytical skills, effective timeline management, adept problem-solving capabilities, and excellent collaboration and teamwork skills are essential for this role. Proficiency in using computer software including Microsoft Office suite, SharePoint, QSAR tools, data mining software, citation tools, and other relevant applications is required. This full-time position is based in Vikhroli, Mumbai, with general shift hours and rare/occasional travel for outdoor duties/monitoring.,