Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist to support global movement of preclinical and early-stage laboratory materials.

Key Responsibilities

• Lead regulatory operations and compliance for international shipments of preclinical and investigational materials
• Assess and advise on permits, documentation, and PGA regulations such as FDA and TSCA
• Develop and establish regulatory frameworks, SOPs, and playbooks to standardize processes

Required Qualifications

• Bachelor's Degree required
• 5+ years of experience in regulatory affairs, regulatory operations, or trade compliance
• Experience supporting international movement of scientific, chemical, or biological materials
• Working knowledge of PGA requirements including FDA and Fish & Wildlife Service
• Strong ability to develop SOPs and interpret evolving regulations