Clinical and Health - Reg Affairs Spec

Mindlance

Richmond, VA

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JOB DETAILS

SKILLS

Analysis Skills, Best Practices, Biology, Chemistry, Clinical Trial, Cross-Functional, Documentation Standards, Error Handling, FDA (Food and Drug Administration), FDA Requirements, Government, Import/Export, Interpret Regulations, Laboratory Operations, Logistics, Operational Support, Pre-Clinical Trials, Problem Solving Skills, Process Analysis, Process Development, Regulations, Regulatory Compliance, Regulatory Requirements, Scalable System Development, Standard Operating Procedures (SOP), Strategic Planning, Supply Chain, Training/Teaching, Work From Home

LOCATION

Richmond, VA

POSTED

30+ days ago

Regulatory Operations & Compliance Preclinical Logistics (PGA Focus)
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.
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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
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Required Qualifications
Experience
" 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
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Preferred Qualifications
" Background in chemistry, biology, or life sciences
" Experience with preclinical or clinical trial materials
" Familiarity with laboratory operations or scientific environments
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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.

About the Company

Mindlance

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