Regulatory Affairs Specialists

Job Summary Regulatory Affairs Specialists Serve as the regulatory lead for Utah DCC projects. Prepare regulatory documents. Ensure timeliness, accuracy, and completeness of regulatory materials. Research regulatory changes that may affect studies. Remain knowledgeable of the regulatory and legal frameworks, regulatory requirements, and legislation applicable to the organization to ensure that studies adhere to all relevant regulatory requirements. Provide recommendations in response to emerging regulatory issues. This position is in the Utah Data Coordinating Center. Join the Utah DCC where we harness the power of collaboration, to advance science, move society, and benefit humanity. We offer opportunities to work with high functioning, cutting-edge teams that study, understand, and improve multi-site research. Bring your strong background in regulatory affairs to the Utah DCC . Autonomy, creativity, and critical thinking skills are strongly encouraged. The Utah DCC offers a career ladder for this position and provides growth and professional development opportunities. Learn more about the Utah DCC : https://uofuhealth.utah.edu/utah-dcc Learn more about the great benefits of working at the University of Utah: https://benefits.utah.edu/ This is posted as open-rank and may be filled at any of the listed job levels. Work Schedule Summary Full-time, 40 hours per week. Monday – Friday Work Location & Residency Residency in the State of Utah is preferred. This position offers a flexible, mostly remote work schedule for candidates who reside in the State of Utah. While most duties can be performed remotely, the employee must be available to attend essential meetings and events on campus as needed. Out of state applicants will be considered. Hiring is contingent upon an out of state approval at the institutional level. Travel This position may require occasional travel.

Responsibilities

Job Responsibilities and Essential Functions Serve as the regulatory lead for Utah DCC projects. Prepare regulatory documents. Ensure timeliness, accuracy, and completeness of regulatory materials. Research regulatory changes that may affect studies. Remain knowledgeable of the regulatory and legal frameworks, regulatory requirements, and legislation applicable to the organization to ensure that studies adhere to all relevant regulatory requirements. Provide recommendations in response to emerging regulatory issues. Serve as the regulatory lead for assigned projects, providing strategic input throughout study planning, execution, and reporting. Provide strategic leadership for interactions with the FDA and other regulatory agencies, including preparation for and participation in regulatory meetings. Develop, implement, and maintain Standard Operating Procedures (SOPs), templates, and regulatory processes to support organizational growth. Ensure audit readiness for all clinical studies by developing processes that ensure compliance with GCP , ICH , and FDA regulations. Draft, review, and finalize regulatory submissions as appropriate (e.g., INDs, amendments, annual reports, clinical study reports). Contribute to the development and review of key study documents, including clinical protocols, informed consent forms, and clinical study reports. Provide regulatory training and mentorship to team members and cross-functional partners. Serve as a regulatory resource to study teams, as appropriate. Critically evaluate the regulatory strategy of potential partners/customers and provide feedback to colleagues within the University of Utah, as appropriate. Stay current with evolving US and global regulatory requirements, proactively communicating relevant updates to leadership and project teams. Conduct staff training sessions on regulatory affairs topics. Department intends to fill one vacancy and may choose to fill at any of the below job levels dependent on business needs and budget. Regulatory Affairs Specialists, II Requires moderate skill set and proficiency in discipline. Conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment. Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience. This is a Developing-Level position in the General Professional track. Expected Pay Range: $50,909 to $77,166 Regulatory Affairs Specialists, III Considered highly skilled and proficient in discipline. Conducts complex, important work under minimal supervision and with wide latitude for independent judgment. Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience. This is a Career-Level position in the General Professional track. Expected Pay Range: $61,599 to $93,370 Regulatory Affairs Specialists, IV Recognized as subject matter expert and advanced individual contributor professional. Requires specialized skill set. Conducts highly complex work, unsupervised and with extensive latitude for independent judgment. Requires a bachelor’s (or equivalency) + 8 years or a master’s (or equivalency) + 6 years of directly related work experience. This is an Advanced-Level position in the General Professional track. Expected Pay Range: $74,535 to $112,978

Minimum Qualifications

EQUIVALENCY STATEMENT : 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor’s degree = 4 years of directly related work experience). Department may hire employee at one of the following job levels: Regulatory Affairs Specialists, II: Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience. Regulatory Affairs Specialists, III : Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience. Regulatory Affairs Specialists, IV: Requires a bachelor’s (or equivalency) + 8 years or a master’s (or equivalency) + 6 years of directly related work experience. Apply tot his job Apply To this Job