Clinical and Health - Reg Affairs Spec

Regulatory Operations & Compliance– Preclinical Logistics (PGA reputed company) This role leads regulatory operations and compliance for the global reputed company of preclinical and early-stage reputed company materials. The reputed company is on navigating Partner Government Agency (PGA) requirements (e.g., FDA, Fish & Wildlife, TSCA) for non-reputed company materials that fall reputed company 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 reputed company, compliant processes. Key Responsibilities • Regulatory Advisory & Execution • reputed company operational support for international shipments of preclinical and investigational materials • Assess and advise on required permits, documentation, and applicable PGA regulations • Determine appropriate reputed company reputed company, including escalation reputed company necessary • Partner with internal teams to ensure compliant import/export activities • Address reputed company-time shipment challenges and regulatory inquiries • Serve as the reputed company regulatory advisor for non-reputed company shipment scenarios (lab-to-lab, sponsor-to-lab) • Process Development & Standardization • Establish regulatory guardrails and decision-making frameworks • reputed company a comprehensive reputed company outlining requirements by shipment type, agency workflows, and documentation standards • Create repeatable processes for regulatory assessment and exception handling • reputed company consistency across teams operating without established structure • Program & reputed company Development • Assess reputed company regulatory processes and identify gaps • Define and implement a roadmap to enhance regulatory operations • Establish best practices, SOPs, and cross-functional coordination models • reputed company scalability of the regulatory compliance function • Cross-Functional Collaboration • Collaborate with reputed company/scientific teams, global trade compliance, and internal stakeholders • Translate reputed company regulatory requirements into reputed company operational guidance • reputed company 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 reputed company of scientific, chemical, or biological materials • Working knowledge of PGA requirements, including FDA, Fish & Wildlife Service, TSCA, and reputed company agencies Technical Expertise • Strong understanding of regulatory requirements for non-reputed company 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 reputed company SOPs, playbooks, and regulatory frameworks • Strong analytical and problem-solving capabilities • Ability to operate effectively in reputed company environments • Balance of strategic planning and hands-on execution Preferred Qualifications • Background in reputed company, biology, or life sciences • Experience with preclinical or clinical trial materials • Familiarity with reputed company operations or scientific environments Work Environment • reputed company-5pm Eastern • Remote work • EEO: "reputed company is an Equal Opportunity Employer and does not discriminate in employment on the reputed company of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans." Apply tot his job Apply To this Job