Senior Toxicology Consultant — Pharma Regulatory Strategy

BlueRidge Life Sciences; Illinois; On-site; USD 140,000 - 190,000; Full time

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist to lead nonclinical safety programs across drug development stages. The role requires deep expertise in regulatory expectations and collaboration with epidemiologists, engineers, and biostatisticians.

The candidate will design and oversee nonclinical safety assessments, draft regulatory sections, interact with agencies such as the FDA, and guide teams through IND/CTA submissions.

Qualifications

• Ph.D. in toxicology or related sciences; DABT desirable but not required.
• Minimum 15+ years in pharmaceutical consulting/industry/government.
• Comprehensive understanding of ICH and regulatory nonclinical guidance.
• Experience overseeing nonclinical safety programs across development phases.
• Experience writing regulatory documents and interacting with agencies.
• Strong communication and ability to work in multidisciplinary teams.

Responsibilities

• Address scientific, regulatory, and business challenges in development of pharma/biopharmaceutical products.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies; interpret safety data.
• Serve as the toxicology representative on project teams.
• Participate in meetings with global regulatory authorities.
• Write or oversee pharmacology/toxicology sections of regulatory submissions.
• Oversee development of reports, expert opinions, and proposals; support due diligence.
• Travel up to ~20% as required.

Skills

Regulatory expertise

Project management

Scientific writing

Cross-functional collaboration

Education

Ph.D. in Toxicology/Pharmacology/related sciences

DABT certification (desired)

Job description

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist to lead nonclinical safety programs across drug development stages. The role requires deep expertise in regulatory expectations and collaboration with epidemiologists, engineers, and biostatisticians.

The candidate will design and oversee nonclinical safety assessments, draft regulatory sections, interact with agencies such as the FDA, and guide teams through IND/CTA submissions.