Associate Director of FDA Compliance

Research Reactor

A life-saving operation in the middle of America - the University of Missouri Research Reactor (MURR) - needs you to help guide its future. MURR is expanding its critical cancer-fighting and medical isotope production.

MURR's reactor is the highest-power university research reactor in the United States, operating at 10 megawatts, 6.5 days a week and 52 weeks a year. The MURR facility enables research across many disciplines - From investigating ancient cultures and how plants respond to their environment, to analyzing industrial materials and developing radiopharmaceuticals that have lifesaving clinical applications. The MURR facility is a reliable resource for researchers, scientists, engineers and students across the country.

Be a part of the future of fighting cancer and saving lives.

Be a part of MURR

The University of Missouri Research Reactor (MURR) is seeking an Associate Director of FDA Compliance. This position will be the primary point of contact, with both customers and regulators, for all regulatory matters related to MURR's human drug products. This role is responsible for ensuring that MURR remains compliant with federal, regional, and international regulations-specifically those outlined by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). The position requires interpretation of Good Manufacturing Practices (GMP) and regulatory frameworks to maintain accurate and compliant programs and submissions.

This position is crucial to ensuring that MURR's regulated activities remain compliant through changing regulations, licensing adjustments, and evolving customer needs. This position will report to the Senior Director of Regulatory Affairs.

Key Duties Performed by This Position Will Include

• Draft and manage technically sound, strategic regulatory submissions, including those related to human drug development and amendments.
• Manage regulatory strategy for MURR's drug products.
• Communicate internally and externally regarding regulatory requirements and strategy.
• Serve as the primary regulatory liaison for health competent authority communications, ensuring timely responses including crisis communications.
• Oversee and coordinate the Regulatory Affairs work stream for current and prospective MURR clients.
• Identify and assess compliance gaps and provide support for resolution efforts and continuous improvement initiatives.
• Support product lifecycle, ensuring regulatory compliance through change control processes.
• Stay up to date with evolving FDA, EMA, and international regulatory guidelines.
• Support and coordinate responses to audits and inspections, including strategic communication and corrective action planning.

This role involves intensive interaction with regulatory agencies, customers, and internal teams. It requires adaptability, problem-solving, and the ability to communicate effectively in a fast-paced and sometimes uncertain environment.

Successful candidates will be persuasive communicators with exceptional organizational and time management skills. They must demonstrate the following durable skills: leadership, character, collaboration, communication, creativity, critical thinking, mindfulness, growth mindset, and fortitude. Additionally, customer service, confidentiality, integrity, and a commitment to university values in their activities.

Must be available for reliable and consistent onsite work.

Monday - Friday, 8AM - 5PM with some work outside of regular schedule when it is required for business

A Master's degree or an equivalent combination of education and experience and at least 5 years of experience from which comparable knowledge and skills can be acquired is necessary.

Prior experience working with regulated nuclear materials or highly specialized industries.
Experience with international regulatory bodies beyond the FDA and EMAs

Salary Range: $125,000.00 - $161,595.00 per year
Grade: GGS-013
University Title: Senior Administrative Consultant
Internal applicants can determine their University title by accessing the Talent Profile tile in myHR.

Columbia offers small-town friendliness with big city features and a high quality of life for people of all ages and interests. Founded on education and known as an ideal college town, its location also makes it an attractive spot for businesses and travelers. Located on Interstate 70 and U.S. Highway 63, Columbia is right in the middle of the state and the nation. Just a couple hours' drive from St. Louis and Kansas City, Columbia is Boone County's largest population center offering big-city culture, activities, and resources with a low cost of living. Columbia is home to a variety of restaurants and entertainment venues and hosts more than a dozen festivals each year. If you want to grow your career, continue your education, raise a family, and retire, Columbia is a good place to be!

This position is eligible for University benefits. As part of your total compensation, the University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, short- and long-term disability, paid parental leave, paid caregiver leave, and educational fee discounts for all four UM System campuses. For additional information on University benefits, please visit the Faculty & Staff Benefits website at https://www.umsystem.edu/totalrewards/benefits.

Equal Employment Opportunity

The University of Missouri is an Equal Opportunity Employer.

To request ADA accommodations, please call the Director of Accessibility and ADA at 573-884-7278.