Beschreibung

You manage impurity and risk assessments to ensure compliance with safety standards. Your role involves collaborating with various teams and providing expert guidance on toxicological evaluations and regulatory matters.

Anforderungen

• •PhD and MSc in Toxicology
• •5–10 years in pharmaceutical toxicology
• •Working knowledge of genetic toxicology
• •Profound knowledge of ICH guidelines
• •Broad understanding of drug development
• •Strong communication and interpersonal skills

Aufgaben

• •Serve as the main contact for impurity and E&L risk assessments.
• •Conduct risk assessments of genotoxic impurities per ICH M7.
• •Perform toxicological evaluations of E&L profiles for various components.
• •Provide guidance on toxicological concern thresholds for safety dossiers.
• •Design and interpret in silico (Q)SAR analyses and propose studies.
• •Draft scientifically justified TBLs for impurities and leachables.
• •Apply risk assessment methodologies according to ICH and EMA/FDA guidelines.
• •Support integration of TBLs into product specifications and validation.
• •Collaborate with teams to ensure compliant control strategies.
• •Work closely with chemists, scientists, and regulatory affairs teams.
• •Evaluate data for the release of new manufacturing batches.
• •Represent Roche in industry consortia and regulatory discussions.
• •Advise project teams on regulatory requests regarding impurities.