We are seeking a Regulatory Compliance & Operations Program Manager to support the global movement of preclinical and investigational laboratory materials across international borders. This role focuses on navigating Partner Government Agency (PGA) regulatory requirements (e.g., FDA, Fish & Wildlife, TSCA) for non-commercial, early-stage materials that do not follow traditional product or supply chain structures.
The ideal candidate will thrive in an unstructured environment, partnering closely with scientific teams and global trade compliance leaders to establish regulatory frameworks, provide real-time guidance, and build scalable processes for compliant material movement.
Key Responsibilities
Regulatory Advisory & Execution
Provide hands-on regulatory support for global shipments of preclinical and investigational materials
Determine and advise on:
Required permits, forms, and documentation
Applicable Partner Government Agency (PGA) regulations (e.g., FDA, Fish & Wildlife, TSCA)
When to escalate regulatory issues vs. resolving internally
Partner with internal teams to:
Ensure compliant import/export of laboratory materials
Address real-time shipment issues and regulatory questions
Serve as the primary regulatory resource for complex or non-standard lab-to-lab shipments
Process Development & Standardization
Build regulatory guardrails and decision-making frameworks
Develop a regulatory playbook outlining:
Requirements by shipment type or scenario
Agency-specific workflows
Documentation standards
Create repeatable processes for:
Determining regulatory requirements
Managing exceptions and edge cases
Improve consistency across teams currently operating without formal regulatory structure
Program & Strategy Development
Conduct an initial assessment of current regulatory gaps and workflows
Design and implement a roadmap for regulatory operations improvements
Establish:
Internal SOPs
Best practices
Cross-functional coordination models
Support the long-term scalability of the regulatory compliance function
Cross-Functional Collaboration
Work closely with:
Scientific and laboratory teams
Global Trade Compliance leadership
Internal stakeholders across multiple business units
Translate complex regulatory requirements into practical operational guidance
Provide training and ongoing regulatory support to non-regulatory personnel
Required Qualifications
Experience
5–10+ years of experience in:
Regulatory affairs
Regulatory operations
Trade compliance
Experience supporting import/export of scientific, chemical, or biological materials
Strong experience working with Partner Government Agencies (PGAs) including:
FDA
Fish & Wildlife Service
TSCA (Toxic Substances Control Act)
Other relevant regulatory bodies
Technical Knowledge
Deep understanding of:
Regulatory requirements for non-commercial / investigational materials
Cross-border shipment compliance in life sciences
Ability to interpret and apply regulations in ambiguous or undefined scenarios
Functional Skills
Experience building:
SOPs
Regulatory playbooks
Compliance frameworks from scratch
Strong problem-solving skills in highly unstructured environments
Ability to balance strategic planning with hands-on execution
Preferred Qualifications
Background in chemistry, biology, or life sciences
Experience working with:
Preclinical or clinical trial materials
Laboratory operations or scientific teams
Seniority level
Not Applicable
Employment type
Contract
Job function
Other
Industries
Hospitals and Health Care
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