Regulatory Specialist

FuseGlobal
  • Saint Louis, Missouri
    28 days ago

    Job Description

    Title: Regulatory Specialist
    Location: St. Louis, MO
    Company: Fortune 100 Food & Beverage Manufacturing (FuseGlobal has worked with this company for 20 years)
    Initial term: 12 months (position expected to run longer)
    Schedule: Monday -Thursday on site; remote Fridays

    *** Must be comfortable working in a pet-friendly environment ***

    About This Role: 

    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.


    What You'll Do:

    • 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.

     

    What You Bring:

    • 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.

     

    Bonus Points:

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

     

    Compensation & Benefits:

    About FuseGlobal:
    FuseGlobal is a partnership of people and brand-leading companies, working together to make things run better. For 25 years we have brought functionality to complex business and production processes and supply chains, resulting in enterprises that run smarter and more sustainably. Interested in digital manufacturing, industrial engineering, supply chain management, all-things tech, and energy & the environment? This is where we live. Engage with us!

    #LI-Onsite
    #LI-FG

    Numbers & Facts

    LocationSaint Louis, Missouri

    Skills

    • Analysis Skillsunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Business Processesunmatched
    • Business Solutionsunmatched
    • Chemistryunmatched
    • Communication Skillsunmatched
    • Cross-Functionalunmatched
    • Disability Insuranceunmatched
    • Document Managementunmatched
    • Documentationunmatched
    • Documentation Standardsunmatched
    • Food Productionunmatched
    • Food and Beverage Industryunmatched
    • Health Insuranceunmatched
    • Import/Exportunmatched
    • Industrial Engineeringunmatched
    • Logisticsunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Monitor Regulationsunmatched
    • Multitaskingunmatched
    • Operational Strategyunmatched
    • Operations Planningunmatched
    • Organizational Skillsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Project/Program Managementunmatched
    • Record Keepingunmatched
    • Regulationsunmatched
    • Regulatory Requirementsunmatched
    • Regulatory Submissionsunmatched
    • Research & Development (R&D)unmatched
    • Research Laboratoryunmatched
    • Risk Analysisunmatched
    • Supply Chain Managementunmatched
    • Time Managementunmatched
    • Writing Skillsunmatched

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