Job Details
Posted 30 April, 2026
Job Id: 627634
Regulatory Operations & Compliance- Preclinical Logistics (PGA Focus)
Job Description
Position Summary
This role leads regulatory operations and compliance for the global movement of preclinical and early-stage laboratory materials. The focus is on navigating Partner Government Agency (PGA) requirements (e.g., FDA, Fish & Wildlife, TSCA) for non-commercial materials that fall outside traditional supply chain structures. The position operates in a dynamic, evolving environment, partnering with scientific and trade compliance teams to establish frameworks, guide daily execution, and build scalable, compliant processes.
Key Responsibilities
Regulatory Advisory & Execution
* Assess and advise on required permits, documentation, and applicable PGA regulations
* Determine appropriate resolution pathways, including escalation when necessary
* Partner with internal teams to ensure compliant import/export activities
* Address real-time shipment challenges and regulatory inquiries
* Serve as the primary regulatory advisor for non-standard shipment scenarios (lab-to-lab, sponsor-to-lab)
Process Development & Standardization
* Develop a comprehensive playbook outlining requirements by shipment type, agency workflows, and documentation standards
* Create repeatable processes for regulatory assessment and exception handling
* Drive consistency across teams operating without established structure
Program & Strategy Development
* Define and implement a roadmap to enhance regulatory operations
* Establish best practices, SOPs, and cross-functional coordination models
* Enable scalability of the regulatory compliance function
Cross-Functional Collaboration
* Translate complex regulatory requirements into clear operational guidance
* Provide training and ongoing support to non-regulatory personnel
Required Qualifications
Experience
* 5+ years 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, Fish & Wildlife Service, TSCA, and related agencies
Technical Expertise
* Experience with cross-border compliance in life sciences
* Ability to interpret and apply regulations in ambiguous or evolving scenarios
Skills
* Strong analytical and problem-solving capabilities
* Ability to operate effectively in unstructured environments
* Balance of strategic planning and hands-on execution
Preferred Qualifications
* Experience with preclinical or clinical trial materials
* Familiarity with laboratory operations or scientific environments
Pay Rate Range: $34.37 – $38.19 depending on experience
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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