Senior Toxicology Consultant — Pharma Regulatory Strategy

BlueRidge Life Sciences; West Virginia; On-site; USD 150,000 - 230,000; Full time

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceutical/pharmaceutical settings) to join the ToxStrategies division, contributing to nonclinical safety assessments and regulatory submissions. The role involves leading toxicology studies, interfacing with regulatory bodies, and guiding project teams through drug development steps.

The candidate will design and oversee nonclinical safety programs, write regulatory sections, and collaborate with

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• 15+ years of pharmaceutical consulting and/or pharmaceutical industry or government experience (FDA) required.
• Strong understanding of ICH and regulatory agency guidance for nonclinical drug development.
• Experience overseeing nonclinical safety programs through all development phases.
• Experience writing regulatory documents (pre-IND packages, INDs, BLAs/NDAs).
• Experience interacting with regulatory agencies and managing complex toxicology projects.

Responsibilities

• Oversee study placement, design, data interpretation, and monitoring of toxicology studies.
• Interpret safety, TK/PK, and PK/PD data for project teams.
• Serve as the toxicology representative on project teams.
• Attend meetings with global regulatory authorities and regulators.
• Write or supervise writing of pharmacology/toxicology sections of regulatory submissions.
• Perform due diligence for in-licensing and out-licensing opportunities.
• Travel up to ~20% may be required.

Skills

Toxicology expertise

Regulatory knowledge

Project management

Scientific communication

Education

Ph.D. in toxicology or related sciences

DABT certification desired

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceutical/pharmaceutical settings) to join the ToxStrategies division, contributing to nonclinical safety assessments and regulatory submissions. The role involves leading toxicology studies, interfacing with regulatory bodies, and guiding project teams through drug development steps.

The candidate will design and oversee nonclinical safety programs, write regulatory sections, and collaborate with