Senior Toxicology Consultant – Pharma Regulatory Strategy

BlueRidge Life Sciences; Clifton (TX); On-site; USD 170,000 - 210,000; Full time

Job summary

BlueRidge Life Sciences seeks an experienced toxicologist (15+ years in biopharmaceuticals) to lead nonclinical safety programs within our ToxStrategies practice. You will design and oversee safety assessments across drug development stages, interpret TK/PK data, and interact with regulatory authorities.

Applicants should have a Ph.D. in toxicology or pharmacology (DABT preferred), strong project management skills, and a track record of regulatory submissions.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences.
• 15+ years of pharma/toxicology experience.
• Familiarity with ICH and regulatory guidance for nonclinical development.
• Experience writing regulatory documents and coordinating with regulatory agencies.

Responsibilities

• Address scientific, regulatory, and business challenges in pharma/biopharmaceutical development.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies.
• Serve as the toxicology representative on project teams.
• Participate in meetings with global regulatory authorities.
• Write or oversee writing of regulatory submission documents (e.g., pre-IND, IND/CTA, NDA/BLA).
• Write or oversee writing of expert opinion reports, waiver requests, presentations, proposals, etc.
• Participate in due diligence meetings for in- and out-licensing.
• Attend and present at toxicology meetings (e.g., ACT, SOT), publish (papers, chapters).
• Conduct business development activities to attract and develop new projects/clients.
• Travel up to approximately 20%.

Skills

Written and verbal communication

Project management

Education

Ph.D. in toxicology/pharmacology or related sciences

DABT certification desired

Job description

BlueRidge Life Sciences seeks an experienced toxicologist (15+ years in biopharmaceuticals) to lead nonclinical safety programs within our ToxStrategies practice. You will design and oversee safety assessments across drug development stages, interpret TK/PK data, and interact with regulatory authorities.

Applicants should have a Ph.D. in toxicology or pharmacology (DABT preferred), strong project management skills, and a track record of regulatory submissions.