Senior Toxicologist - Nonclinical Safety & Regulatory Expert

BlueRidge Life Sciences; Montgomery (AL); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive compensation

Benefits package

Professional development

Job summary

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceutical/pharmaceutical settings) to join our ToxStrategies division. The role involves leading nonclinical safety programs, interfacing with regulatory authorities, and guiding regulatory documentation from pre-IND through NDA/BLA stages.

You will collaborate with toxicologists, epidemiologists, engineers, and biostatisticians, contributing to strategic decisions, study design, and client-facing guidance.

Qualifications

• Ph.D. in toxicology or related sciences; DABT certification is desired but not required.
• 15+ years of pharmaceutical consulting and/or pharmaceutical industry and/or government experience (FDA) required.
• Comprehensive understanding of ICH and regulatory agency guidance documents for nonclinical drug development.
• Experience overseeing nonclinical safety assessment programs through all development phases (pre-IND to marketing).
• Experience writing regulatory documents (pre-IND packages, INDs, BLAs/NDAs) and interacting with regulatory agencies.
• Strong project management skills to oversee multiple high-priority programs with tight timelines.
• Demonstrated written and verbal communication skills; ability to work independently or in multidisciplinary teams.

Responsibilities

• Address scientific, regulatory, and business challenges in development of pharmaceutical/biopharmaceutical products.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies; interpret safety data.
• Serve as the toxicology representative on project teams and participate in meetings with global regulatory authorities.
• Write or oversee writing of pharmacology/toxicology sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA).
• Write or oversee expert opinion reports, waiver requests, and proposals; participate in due diligence
• Attend toxicology meetings (ACT, SOT); publish papers or book chapters as appropriate.
• Engage in business development activities to attract new projects; travel may be required up to ~20%.

Skills

Project management

Regulatory writing

Scientific communication

Team leadership

Regulatory affairs

Independent work

Cross-functional collaboration

Education

Ph.D. in Toxicology

DABT certification desired

Job description

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceutical/pharmaceutical settings) to join our ToxStrategies division. The role involves leading nonclinical safety programs, interfacing with regulatory authorities, and guiding regulatory documentation from pre-IND through NDA/BLA stages.

You will collaborate with toxicologists, epidemiologists, engineers, and biostatisticians, contributing to strategic decisions, study design, and client-facing guidance.