Regulatory Toxicologist – Global Nonclinical Safety

About the role

Bayer is seeking a Regulatory Toxicologist to lead non‑clinical safety activities for its global portfolio of marketed products. You will apply toxicological science to protect patients, support manufacturing safety, and ensure regulatory compliance worldwide.

Key responsibilities

• Take global responsibility for nonclinical safety issues, including impurity and extractables/leachables assessment.
• Derive health‑based exposure limits (e.g., PDEs) for cleaning validation and occupational safety, and advise production teams.
• Provide toxicological expertise for manufacturing, occupational safety, and quality topics to maintain Bayer’s compliance.
• Develop integrated testing strategies aligned with regulatory frameworks such as the Medical Device Regulation.
• Oversee in‑vitro and in‑vivo toxicology studies performed by external CROs and evaluate the resulting data.
• Support interactions with health authorities and contribute to successful regulatory submissions across regions.
• Conduct scientific peer reviews to ensure high quality, rigor, and regulatory compliance across projects.

Required profile

• University degree in medicine, veterinary medicine, pharmacy, chemistry or another natural science; preferably a PhD, MD or equivalent.
• More than five years of relevant pharmaceutical industry experience, including several years in toxicology for marketed products and occupational toxicology.
• Proven ability to develop integrated substance‑characterisation strategies and support regulatory compliance across multiple frameworks.

Required skills

• Toxicological risk assessment
• Impurity and extractables/leachables evaluation
• Derivation of health‑based exposure limits (PDEs)
• Design and oversight of in‑vitro and in‑vivo toxicology studies
• Regulatory submission preparation and interaction with health authorities

What we offer

• Opportunity to influence patient safety on a global scale
• Collaborative environment with diverse scientific expertise
• Access to cutting‑edge research and development resources