Toxicologist with Regulatory Module Writing Experience- AM-Remote

• 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.

Required Experience

• 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.

Qualifications :

PhD / . in Toxicology Pharmacology Life Sciences

Remote Work :

Yes

Employment Type :

Full-time