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

- Strong 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.
- Strong 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