Senior Regulatory Affairs Specialist

Why RTI RTI International is an independent, scientific research institute dedicated to improving the human condition. Our vision is to address the world's most critical problems with technical and science-based solutions in pursuit of a better future. Clients rely on us to answer questions that demand an objective and multidisciplinary approach- one that integrates expertise across social, statistical, data, and laboratory sciences, engineering, and other technical disciplines to solve the world's most challenging problems. We believe in the promise of science and technical solutions, and we push ourselves every day to deliver on that promise for the good of people, communities, and businesses in the US and around the world. If you are looking for the opportunity to make a real difference, RTI is the place for you. About the Hiring Group 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. What You'll Do Serving 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 #LI-BM1 EEO & Pay Equity Statements For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is availablehere. RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. For Applicants in Massachusetts Only:It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer. At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a 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, an employee assistance program, and numerous other offerings to support a healthy work-life balance. Equal Pay Act Minimum/Range $125,000.00-$220,000.00 #J-18808-Ljbffr