Senior Regulatory Toxicologist

Category: Research

Location:Måløv, Capital Region of Denmark, DK

• Preparing toxicological risk assessments of drug product and process-related impurities, as well as evaluating extractables & leachables from production equipment and primary packaging materials, while maintaining a balance between regulatory requirements and scientific rigor.
• Engaging in toxicological assessment and communication of environmental and occupational safety of drug candidates for production facilities, along with the biological evaluation of devices.
• Leveraging literature data, in silico models, in-vitro models, and biological testing to conduct toxicological safety assessments, overseeing studies conducted at internal or external laboratories or by in-silico consultants.
• Actively contributing to process improvements and the implementation of digital solutions.

• A master's degree or Ph D in chemical/biochemical, life sciences, or a related field, coupled with a solid understanding of toxicology.
• At least 3 years of experience in toxicological risk assessment, with a strong familiarity of guidelines and regulations, including ICHM7, ICHQ3C, and ICHQ3D.
• Proficiency in in-silico evaluations and experimental work, either through direct involvement or collaboration with contract research organizations.
• The ability to manage multiple tasks, diverse stakeholders, and tight deadlines without compromising on quality.
• An innovative mindset, coupled with a keen interest in exploring digital solutions and driving process enhancements.