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."