Principal Regulatory Toxicology Specialist

Role Summary

The Principal Regulatory Toxicologist will participate in strategy for nonclinical testing of investigational and marketed products and manage preparation of regulatory dossiers. They will interact with cross-functional teams to develop submission strategies for nonclinical sections of regulatory documents. They will provide expert evaluation and reporting of drug safety related to nonclinical toxicology. This on-site role is located in Summit, NJ.

Responsibilities

• Interpret nonclinical data in line with the study protocol design and execution, ensuring adherence to regulatory requirements and responding to relevant regulatory requests.
• Contribute to the preparation of regulatory submissions including INDs, NDAs, and BLAs, including preparation of written and tabular nonclinical summaries.
• Contribute to the preparation or review of documents including study reports, investigator brochures, pharmacy manuals, protocols, drug labeling and safety data sheets.
• Provide expert opinion on toxicology studies planned or performed.
• Contribute to the design, monitoring, and reporting of toxicology studies.
• Interact with other functional areas, such as environmental health and safety, when needed to address toxicology related matters.
• Create, edit, and adhere to standard operating procedures as needed.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs.

Qualifications

• Required: Master’s Degree in life sciences or equivalent with 8+ years of toxicology regulatory experience in the biotech or pharmaceutical industry.
• Required: Doctorate Degree in life sciences or equivalent with 6+ years of toxicology regulatory experience in the biotech or pharmaceutical industry.
• Required: Experience in interpreting nonclinical data and writing nonclinical sections of reports and regulatory submissions.
• Required: Expert knowledge of Health Authority nonclinical guidance documents and requirements.
• Required: Experience with organizing responses to Health Authority requests.
• Preferred: Experience as a Study Director/Study Monitor with ability to design and execute toxicology studies to determine the nonclinical safety of therapeutics.
• Preferred: Experience with regulatory submissions outside of the US.

Skills

• Strong knowledge in therapeutic areas of oncology and metabolic diseases.
• Familiar with the use and application of computational toxicology tools to utilize in-silico modeling for compliance efforts.
• Strong knowledge of toxicokinetics as well as bioanalytical method development and validation.
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
• Strong organizational skills, written and oral communication skills, and attention to detail.

Additional Requirements

• This position works on-site in Summit, NJ.
• A Principal Regulatory Toxicologist may need to sit for long periods of time and use various computer programs.
• This desk-based role involves the close study of scientific and regulatory documents.
• They will work closely with scientific colleagues throughout the day, often on a project team basis.