About the Hiring GroupThe Senior Nonclinical Regulatory Affairs Scientist is a consulting, client-facing leader who provides strategic nonclinical, translational, and regulatory expertise for the development of drugs, biologics, vaccines, and other medical products.
As a key member of a multidisciplinary team within RTI's Laboratory Sciences and Engineering (LS&E) division, you will partner closely with scientists and technical experts to accelerate early-stage product development aimed at addressing some of the most critical unmet needs in healthcare. This is an opportunity to play a meaningful role in translating cutting-edge research into real-world impact.
What You'll DoServing as a subject matter expert in nonclinical safety (toxicology and safety pharmacology) and regulatory strategy, you will partner with clients and project teams to design and execute development programs that support advancement from discovery through clinical development and regulatory approval.
You will provide scientific and regulatory leadership across a diverse portfolio of commercial, government, and global health projects, translating complex nonclinical data into actionable development and regulatory strategies. Additionally, you will collaborate closely with clients, sponsors, CROs, and multidisciplinary internal teams to advance product development programs, mitigate development risks, and support successful interactions with regulatory health authorities.
This position serves as a trusted advisor to clients, contributing to business development activities, proposal preparation, client engagement, and strategic growth initiatives within RTI's product development and regulatory consulting portfolio.
Key Responsibilities- Develop nonclinical regulatory strategies to support IND submissions.
- Provide scientific leadership for nonclinical development programs across a broad range of therapeutic modalities, including small molecules, biologics, vaccines, anti-infectives, and emerging health technologies.
- Design and oversee IND-enabling programs, including toxicology, safety pharmacology, biodistribution, development and reproductive toxicity, and other nonclinical studies, as appropriate.
- Provide strategic guidance on study design, species selection, dose selection, translational relevance, and regulatory risk mitigation.
- Monitor and manage outsourced nonclinical studies conducted at CROs, ensuring scientific quality, regulatory compliance, and alignment with project objectives.
- Interpret pharmacology, toxicology, and safety data and translate findings into development and regulatory recommendations.
- Author and review nonclinical sections of regulatory documents and responses to the FDA
- Participate in regulatory interactions with the FDA.
- Collaborate with multidisciplinary teams including toxicology, quality, clinical, and program management on a portfolio of projects
- Contribute to proposal development, business development activities, client relationship management, and growth initiatives.
What You'll Need- PhD in Toxicology, Pharmacology, Pharmaceutical Sciences, Veterinary Medicine, or related life science discipline.
- 8+ years of nonclinical medical product development experience.
- Experience supporting INDs submissions
- Strong knowledge of FDA, ICH, and GLP regulations.
- Experience monitoring outsourced nonclinical toxicology and safety pharmacology at CROs
- Demonstrated ability to communicate complex scientific and regulatory concepts to clients, regulators, and multidisciplinary teams.
- Experience managing multiple projects and working effectively in a consulting or client-service environment.
- Prior experience in a consulting organization, CRO, pharmaceutical, or biotechnology company.
Competencies- Nonclinical development strategy
- Regulatory submissions and agency interactions
- Toxicology and safety assessment
- Scientific and regulatory writing
- Cross-functional leadership and ability to work effectively on a team
- Ability to effectively manage time across multiple projects and clients
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Hiring Salary Range$125,000.00-$220,000.00
