Regulatory Affairs Specialist

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 structureProgram & 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 functionCross-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 QualificationsExperience•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 agenciesTechnical 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 scenariosSkills•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