Senior Pharmaceutical Toxicologist - Regulatory Strategy

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

Job summary

BlueRidge Life Sciences is seeking a senior toxicologist for the ToxStrategies practice in the United States. The role targets professionals with 15+ years in biopharmaceuticals, consulting, or regulatory settings who can lead nonclinical safety programs and interact with agencies across development stages.

You will oversee study design, data interpretation, and regulatory writing, guiding teams through IND/CTA, NDA/BLA, and other submissions.

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required
• Minimum 15+ years of pharmaceutical consulting and/or pharmaceutical industry and/or government experience (e.g., FDA)
• Comprehensive understanding of ICH and regulatory guidance for nonclinical development
• Experience overseeing nonclinical safety programs through all development phases
• Experience writing regulatory sections and interacting with agencies
• Experience managing complex, high-priority programs and timelines
• Demonstrated written and verbal communication skills
• Ability to work independently or in multidisciplinary teams
• Active involvement in toxicology/science professional organizations with publications/presentations

Responsibilities

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical development
• Oversee study placement, data interpretation, and safety data from toxicology studies
• Serve as the toxicology representative on project teams
• Interact with global regulatory authorities in meetings
• Write or oversee nonclinical sections of regulatory submissions
• Draft expert opinions, proposals, and regulatory documents
• Contribute to due diligence for in/out-licensing
• Attend toxicology meetings and publish in professional forums
• Engage in business development to attract new projects/clients
• Travel up to ~20% may be required

Skills

Toxicology expert

Regulatory strategy

Project management

Scientific writing

Team leadership

ICH guidelines

Education

Ph.D. in Toxicology or Pharmacology

DABT certification desired

Job description

BlueRidge Life Sciences is seeking a senior toxicologist for the ToxStrategies practice in the United States. The role targets professionals with 15+ years in biopharmaceuticals, consulting, or regulatory settings who can lead nonclinical safety programs and interact with agencies across development stages.

You will oversee study design, data interpretation, and regulatory writing, guiding teams through IND/CTA, NDA/BLA, and other submissions.