Regulatory Affairs Specialist

Regulatory Affairs Specialist Date: Jul 6, 2026 Location: St. Louis, MO, United States, 63146 About Curium Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world‑class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life‑threatening diseases to over 14 million patients annually. The name "Curium" honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline "Life Forward" represents our commitment to securing a brighter future for all those we serve: an enhanced quality of care for our patients, a trusted partner to our customers, and a supportive employer to our valued team. Summary of Position The Regulatory Affairs Product Specialist responsibilities encompass the support of US FDA applications (NDAs, ANDAs, DMFs) and international drug product applications. Support of regulatory activities includes but is not limited to: Plan, author, compile and submit statutory reports in eCTD format for marketed products per FDA requirements. Review and assess CMC regulatory impact of post‑approval changes proposed at the manufacturing site and provide regulatory strategy. Plan, author, compile, submit and manage variations and supplements for marketed products within and outside the United States. Participate in cross‑functional teams and provide health‑authority requirements needed for support of post‑approval changes. Author or review updates to marketed product labeling. Maintain regulatory knowledge of current guidelines and regulations. Maintain current regulatory databases and produce various reports as needed. Utilize and support electronic document management systems. Provide mentorship for entry‑level regulatory associates. Work schedule: Monday – Friday 8:00 a.m. – 5:00 p.m. Essential Functions Maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.). Author, organize and prepare electronic (eCTD) regulatory filings; also includes peer review of filings. Understand and identify potential regulatory risks and recommend strategies based on current FDA/health‑authority requirements. Manage multiple priorities. Attend necessary trainings and seminars to stay abreast of new and/or changes in the regulatory profession. Critically review documentation for regulatory submissions and provide input for necessary revisions. Requirements Bachelor’s degree in a scientific discipline required or equivalent work experience. Minimum of three years of regulatory experience or related field. Cross‑functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments. Project leadership experience preferred. Strong organizational skills, strong attention to detail, ability to problem‑solve and to work well with others and cross‑functionally. Excellent written and oral communication skills. Use of change controls software system. Strong background using Microsoft Office tools and Adobe Acrobat. Working Conditions Standard office environment. Willingness to work in a team‑based environment. Close attention to detail required. May be required to sit or stand for long periods (8+ hours a day) while performing duties. The position deals with many deadlines; due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required. Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Equal Opportunity Employer Curium is an equal‑opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We believe diversity includes disability, and we actively encourage applications from people with disabilities. If you require any accommodations during the recruitment process, please let us know – we are happy to support you. #J-18808-Ljbffr