Designation: Senior Research Officer
Location: Mahape, Navi Mumbai
Job Description:
The Senior Research Officer will be responsible for conducting advanced toxicological assessments in a dry lab workplace, supporting regulatory compliance, and ensuring the safety and quality. The role involves risk assessment, impurity evaluation, dossier preparation, and implementation of contamination control strategies aligned with global regulatory expectations.
Key Responsibilities:
1. Evaluate toxicological literature, including in vivo/in vitro studies, to identify potential hazards, adverse effects, and dose-response relationships.
2. Conduct hazard identification, toxicological data reviews, and risk assessments to ensure compliance with EMA/FDA, ICH, and EHS regulations.
3. Develop and update Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) reports for APIs, ensuring safety for patients and cleaning validation
4. Establish Occupational Exposure Limits (OEL)
and banding for chemical substances to protect workers
5. Ensure all documentation (monographs) meets regulatory standards (EMA/FDA/PIC/S).
6. Provide input on classification of therapeutic and hazardous categories, cross-contamination, and mitigation strategies for cleaning validation.
7. Perform in silico (QSAR) prediction analysis and interpretation of the alerts
8. Determine the F value and provide inputs to aid child-resistant packaging
9. Collate the relevant nonclinical information (pharmacology, pharmacokinetics, and toxicology) for the drugs to assist in compiling Module 2 for regulatory submission.
Qualification and Experience:
1. Master's degree in Toxicology, Pharmacology, or a related field (e.g., Biochemistry).
2. 5 to 7 years of experience in regulatory toxicology and chemical risk assessment