Regulatory Specialist

Job Summary:
Support R&D projects by providing regulatory guidance and coordinating import/export requirements for research samples. Maintain regulatory plans, documentation, and compliance activities while partnering with R&D, Quality, Operations, Logistics, and external stakeholders.

Key Responsibilities:

• Support regulatory requirements for R&D projects and sample shipments.
• Develop and maintain regulatory plans and documentation.
• Monitor applicable regulations and internal procedures.
• Coordinate import/export compliance for research samples.
• Identify and escalate regulatory risks or shipment issues.
• Partner with cross-functional teams to resolve compliance questions.
• Support process improvements and regulatory recordkeeping.

Qualifications:

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Chemistry, Biology, or related field.
• Experience in regulatory, laboratory, pharmaceutical, biotech, or life sciences preferred.
• Knowledge of research sample import/export regulations preferred.
• Strong organization, communication, analytical, and problem-solving skills.
• Proficiency with documentation and standard business software.