Regulatory Affairs Specialist

Richmond, Virginia
May 4, 2026
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Job Description

Job 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.

Duties and Responsibilities:

Regulatory Advisory & Execution:

  • Provide operational support for international shipments of preclinical and investigational materials.
  • 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:

  • Establish regulatory guardrails and decision-making frameworks.
  • 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:

  • Assess current regulatory processes and identify gaps.
  • 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:

  • Collaborate with laboratory/scientific teams, global trade compliance, and internal stakeholders.
  • Translate complex regulatory requirements into clear operational guidance.
  • Provide training and ongoing support to non-regulatory personnel.

Education and Experience:

  • Bach. Degree required.
  • 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:

  • Strong understanding of regulatory requirements for non-commercial or investigational materials.
  • Experience with cross-border compliance in life sciences.
  • Ability to interpret and apply regulations in ambiguous or evolving scenarios.

Skills:

  • Proven ability to develop SOPs, playbooks, and regulatory frameworks.
  • Strong analytical and problem-solving capabilities.
  • Ability to operate effectively in unstructured environments.
  • Balance of strategic planning and hands-on execution.

Preferred Qualifications:

  • Background in chemistry, biology, or life sciences.
  • Experience with preclinical or clinical trial materials.
  • Familiarity with laboratory operations or scientific environments.

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