Role & responsibilities
Serve as Study Director in compliance with GLP regulations (OECD, USFDA, EU EMA guidelines).
Design, plan, execute, and oversee preclinical toxicology studies, primarily in rodent models (rats/mice) and also in non-rodents.
Ensure effective conduct of studies including:
Sub-acute, sub-chronic, and chronic toxicity studies
Toxicokinetics (TK)
MTD/Dose range finding studies
Act as the single point of study control, ensuring integrity and scientific quality of data.
Prepare, review, and finalize study protocols, amendments, and reports in compliance with regulatory requirements.
Author and submit GLP-compliant study reports for regulatory filings (e.g., US FDA, EMA/EU submissions).
Provide scientific interpretation of toxicological findings and risk assessment.
Collaborate with cross-functional teams including:
Pathology
Analytical/TK
Formulation
Participate in client interactions, study discussions, and audits.
Support regulatory inspections (USFDA, MHRA, EMA, etc.) and respond to queries.
Ensure compliance with SOPs, GLP standards,



and animal welfare regulations.
Mentor and guide junior scientists and study personnel.

Preferred candidate profile
Robust knowledge of preclinical toxicology principles, especially in rodent models.
Hands-on experience with GLP toxicology studies in a CRO workplace.
Thorough understanding of:
OECD guidelines
ICH guidelines (M3, S and Q series)
USFDA and EMA regulatory requirements
Expertise in Provantis, data analysis, interpretation, and reporting of toxicological endpoints.
Familiarity with toxicokinetics and bioanalytical data interpretation.
Robust documentation and technical writing skills for regulatory submissions.
Experience handling regulatory audits and inspections.
Excellent communication and client-facing skills.
Ability to manage multiple studies and timelines efficiently.

Qualifications
PhD / MPharm / MSc in Toxicology, Pharmacology, Life Sciences, or related field.
Certification in ERT or DABT (preferred).

📌 Toxicology Study Director Pune
🏢 Aragen Life Sciences
📍 Pune