Regulatory Affairs Specialists

Regulatory Affairs Specialists

Serve as the regulatory lead for Utah DCC projects. Prepare regulatory documents and ensure timeliness, accuracy, and completeness of regulatory materials. Research regulatory changes that may affect studies, remain knowledgeable of the regulatory and legal frameworks, and provide recommendations in response to emerging regulatory issues.

Full-time, 40 hours per week. Monday – Friday

Residency in Utah preferred. Mostly remote with occasional campus meetings. Out-of-state applicants may apply under institutional approval.

This position may require occasional travel.

Serve as the regulatory lead for projects and manage regulatory processes.

• Provide strategic input during study planning, execution, and reporting.
• Lead interactions with the FDA and other regulatory agencies, including preparation for regulatory meetings.
• Develop, implement, and maintain SOPs, templates, and regulatory processes.
• Ensure audit readiness across clinical studies for GCP, ICH, and FDA regulations.
• Draft, review, and finalize regulatory submissions such as INDs, amendments, annual reports, and clinical study reports.
• Contribute to development and review of key study documents (protocols, consent forms, reports).
• Provide regulatory training and mentorship to team members and partners.
• Serve as a regulatory resource to study teams.
• Critically evaluate regulatory strategies of partners/customers.
• Stay current with evolving US and global regulatory requirements; communicate updates to leadership.
• Conduct staff training sessions on regulatory affairs topics.

Moderate skill level. Bachelor’s + 4 years or Master’s + 2 years of directly related experience. Developing‑Level position.

Expected Pay Range: $50,909 to $77,166

Highly skilled. Bachelor’s + 6 years or Master’s + 4 years of directly related experience. Career‑Level position.

Expected Pay Range: $61,599 to $93,370

Subject matter expert. Bachelor’s + 8 years or Master’s + 6 years of directly related experience. Advanced‑Level position.

Expected Pay Range: $74,535 to $112,978

EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience.

• Bachelor’s (or equivalency) + 4 years of related experience.
• Master’s (or equivalency) + 2 years of related experience.

• Advanced degree (MS, Pharm
  
  D, PhD, MD).
• Global regulatory experience.
• Deep understanding of ICH GCP, FDA, and international regulatory guidelines.
• Proven ability to lead regulatory strategy and execution for complex clinical programs.
• Bachelor’s degree in life sciences, regulatory affairs, or related field.
• Minimum 10 years’ regulatory affairs experience within a regulatory agency or industry.
• Experience interacting directly with FDA or other regulatory authorities.
• Strong knowledge of US regulatory requirements (IND, IDE, emergency IND, NDA, etc.).
• Excellent scientific writing and document review skills.
• Strong organizational skills managing multiple projects.
• High attention to detail and commitment to quality.

Consistent with state and federal law, the University of Utah does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy‑related conditions, genetic information, or protected veteran’s status. The University of Utah does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106.

The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.

The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service may elect to enroll in URS if they make the election…