Regulatory Specialist

FuseGlobal•St. Louis, MO

8d•Hybrid

About The Position

The Regulatory Specialist provides import and export support for research samples, including documentation coordination and shipment compliance guidance. The specialist ensures communication is timely and follows up with stakeholders as needed for sample shipment, research and development projects by providing regulatory guidance, developing regulatory plans, and coordinating import and export support for research samples. This role partners with cross-functional teams to help ensure project activities align with applicable regulatory requirements, internal policies, and business timelines.

Requirements

Bachelor’s degree in life sciences, regulatory affairs, chemistry, biology, or a related field.
Experience supporting regulatory activities in a research, laboratory, life sciences, pharmaceutical, biotechnology, or related environment preferred.
Strong organizational skills with the ability to manage multiple projects and deadlines.
Excellent written and verbal communication skills.
Ability to analyze regulatory information and apply it to business and project needs.
Proficiency with documentation management and standard business software.
Detail-oriented with strong problem-solving and collaboration skills.

Nice To Haves

Knowledge of regulatory requirements related to research activities and import/export of research samples

Responsibilities

Support R&D teams on regulatory requirements for research and development projects.
Develop and maintain regulatory plans to support project goals, timelines, and compliance needs.
Monitor applicable regulations, guidance, and internal procedures that may affect research activities and sample movement.
Collaborate with cross-functional partners, including R&D, quality, operations, logistics, and external stakeholders, to address regulatory questions and resolve issues.
Prepare, organize, and maintain regulatory records, submissions, correspondence, and supporting documentation.
Assist in risk identification and escalation related to regulatory requirements, timelines, or shipment constraints.
Contribute to process improvements that strengthen regulatory planning and operational efficiency.
Communicate regulatory requirements clearly to project teams and provide day-to-day compliance support.