REGULATORY OPERATIONS & COMPLIANCE- PRECLINICAL LOGISTICS (PGA FOCUS)

Overview Regulatory Operations & Compliance- Preclinical Logistics (PGA Focus) Location: Remote, North Carolina Category: Clinical Development and Operations Salary: Apply for details Country: United States Employment: Contract Worksite: On-Site Job Description Position Summary 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 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 Experience 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 Pay Rate Range: $34.37 – $38.19 depending on experience Equal Opportunity We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. Fraud Alert Note: For safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process, and verify recruiter email domains to ensure they are official. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. #J-18808-Ljbffr Planet Pharma