About the job
Core
Conduct non-clinical pharmacology and toxicology evaluations for generic drugs, combination products, and new drug candidates.
Role type
Non-clinical pharmacology and toxicology researcher
Builds
Non-clinical safety data packages for regulatory submissions
Domain
Pharmaceutical industry, non-clinical drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Non-clinical study design (in vitro, in vivo), toxicology evaluation (safety pharmacology, genotoxicity, reproductive, repeated dose), bioequivalence testing, regulatory guideline knowledge (MFDS, ICH, OECD, FDA, EMA), data analysis
Preferred skills
Licensed pharmacist, PhD in related field
Technologies
N/A
Responsibilities
Develop and analyze strategies for non-clinical efficacy, pharmacokinetics, and toxicity studies; Select and manage external CROs; Evaluate non-clinical data and prepare regulatory submission documents
Seniority
Entry-level to Mid-level (0-5 years experience)
