Regulatory Affairs Specialist

Job Summary

Regulatory Affairs Specialist, a full-time temporary position, is responsible for leading regulatory operations and compliance for the international shipment of preclinical laboratory materials.

Key Responsibilities

• Lead regulatory operations and compliance for international shipment of preclinical laboratory materials
• Assess and advise on permits, documentation, and PGA regulations
• Develop regulatory frameworks, SOPs, and collaborate with internal teams for compliance

Required Qualifications

• Bachelor's Degree in a relevant field (e.g., Chemistry, Biology)
• 5+ years of experience in regulatory affairs or trade compliance
• Experience with international movement of scientific or biological materials
• Working knowledge of PGA requirements such as FDA and TSCA
• Proven ability to develop SOPs and manage cross-border compliance