Senior Toxicology Lead – Pharma Consulting & Regulatory

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

Job summary

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals or consulting to lead nonclinical safety programs and regulatory submissions. The role involves coordinating studies, interpreting safety data, and serving as the cosmetic toxicology representative on project teams.

You will interact with global regulatory authorities, contribute to pre-IND packages, and support business development. Travel up to 20% is possible; a Ph.D.

Qualifications

• Ph.D. required with extensive drug development knowledge.
• Experience in nonclinical safety assessment and regulatory submissions.
• Strong written and verbal communication; able to lead teams.

Responsibilities

• Oversee nonclinical safety programs across development phases.
• Draft/regulatory write-ups (pre-IND, IND/CTA, NDA/BLA) and review reports.
• Interact with regulatory agencies (FDA, EMA, MHRA).
• Lead business development and client engagements; travel up to 20%.

Skills

Project management

Written communication

Verbal communication

Independent work

Team collaboration

Scientific writing

Regulatory liaison

Publications

Education

Ph.D. in toxicology/pharmacology or related

DABT certification desired

Job description

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years in biopharmaceuticals or consulting to lead nonclinical safety programs and regulatory submissions. The role involves coordinating studies, interpreting safety data, and serving as the cosmetic toxicology representative on project teams.

You will interact with global regulatory authorities, contribute to pre-IND packages, and support business development. Travel up to 20% is possible; a Ph.D.