Regulatory Affairs Specialist

Regulatory Affairs Specialist

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.

Responsibilities

• 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).
• 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.
• 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.
• 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.

Essential Skills

• 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.
• 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.
• 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.

Additional Skills & Qualifications

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

Work Environment

The position is remote with working hours from 8am to 5pm Eastern. It is a contingent role within the United States, focusing on regulatory and compliance operations in the medical and scientific sectors.

Job Type & Location

This is a Contract position based out of Richmond, VA.

Pay and Benefits

The pay range for this position is $34.37 - $38.19/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Jun 3, 2026.