Senior Nonclinical Regulatory Affairs Scientist
About The Position
The 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.
Requirements
- 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.
Nice To Haves
- 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
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.
Benefits
- competitive base salary
- generous paid time off policy
- merit based annual increases
- bonus opportunities
- robust recognition program
- competitive range of insurance plans (including health, dental, life, and short-term and long-term disability)
- access to a retirement savings program such as a 401(k) plan
- paid parental leave for all parents
- financial assistance with adoption expenses or infertility treatments
- financial reimbursement for education and developmental opportunities
- employee assistance program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
