Toxicologist with Regulatory Module Writing Experience

About This Role

Conducting toxicological risk assessments for pharmaceutical, consumer health, and combination products is the core of this role, ensuring compliance with global regulatory requirements. The position suits a candidate with a strong background in toxicology and regulatory submissions who can navigate complex scientific evaluations and contribute to product safety assessments.

Responsibilities

• Conduct toxicological risk assessments for pharmaceutical, consumer health, and combination products, ensuring compliance with global regulatory requirements.
• Perform impurity qualification assessments in accordance with ICH guidelines, including evaluation of genotoxic, mutagenic, and process-related impurities.
• Review toxicological literature, safety databases, regulatory guidance documents, and published evidence to support product safety assessments and regulatory decision-making.
• Develop and author toxicology reports, risk assessment documents, expert opinions, and regulatory submission content.
• Lead preparation and review of non-clinical modules for regulatory dossiers.
• Provide scientific justification for toxicological endpoints, acceptable daily exposures (ADE/PDE), impurity limits, safety margins, and risk mitigation strategies.
• Support regulatory submissions by preparing toxicological summaries, risk-benefit evaluations, and responses to agency questions.
• Evaluate non-clinical and published data to support impurity qualification, extractables and leachable assessments, and product safety profiles.
• Monitor evolving global regulations and guidance documents (ICH, FDA, EMA, WHO, and regional requirements) relevant to toxicology and impurity assessment.

Requirements

• 3-5 years of experience in toxicology, safety assessment, or regulatory toxicology within the pharmaceutical, consumer health, or life sciences industry.
• Hands-on experience in impurity qualification and toxicological evaluation of pharmaceutical substances and products.
• Proven experience in authoring and reviewing toxicology modules for CTD/eCTD submissions.
• Strong knowledge of ICH guidelines, particularly ICH M7, Q3A, Q3B, and relevant toxicology regulations.
• Experience conducting literature reviews, safety assessments, and preparing scientific justifications for regulatory submissions.
• Excellent scientific writing, interpretation, and stakeholder management skills.

Benefits

• Opportunity to work with a leading company in intelligent operations and transformation.
• Engage with a diverse range of clients across multiple industries.
• Collaborate with a global team of experts in toxicology and regulatory affairs.

Important Details