Clinical and Health - Reg Affairs Spec

Regulatory Operations & Compliance– Preclinical Logistics (PGA Focus) 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
• 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

Required Qualifications

• 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

Work Environment

• 8am-5pm Eastern
• Remote work
• EEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."