Regulatory Compliance Manager

Title:

Regulatory Compliance & Operations Program Manager

Pay rate:

$95-100 an hour | 40 hour work week

Remote

Job Description:

Regulatory Operations & Compliance Program Manager – Preclinical Logistics (PGA Focus)

Position Overview:

We are seeking a Regulatory Operations & Compliance Lead to support global movement of preclinical and clinical laboratory materials across international borders. This role will focus specifically on navigating Partner Government Agency (PGA) requirements (e.g., FDA, Fish & Wildlife, TSCA) for non-commercial, early-stage materials that do not follow traditional product or supply chain structures.

This individual will operate in a highly unstructured environment, partnering directly with scientific and trade compliance teams to establish regulatory frameworks, provide day-to-day guidance, and build scalable processes for compliant material movement.

Key Responsibilities:

Regulatory Advisory & Execution (Day-to-Day)

• Provide hands‑on support for global shipments of preclinical and investigational materials
• Determine and advise on:
• Required permits, forms, and documentation
• When to elevate vs. internally resolve regulatory decisions
• Partner with internal teams to:
• Ensure compliant import/export of lab materials
• Address real‑time shipment issues and regulatory questions
• Serve as the primary regulatory resource for non‑standard, lab‑to‑lab shipments
• Build regulatory guardrails and decision‑making frameworks
• Develop a playbook outlining:
• Requirements by shipment type/scenario
• Agency‑specific workflows
• Documentation standards
• Determining regulatory requirements
• Handling exceptions and edge cases
• Improve consistency across teams currently operating without formal structure
• Conduct an initial assessment of current regulatory gaps and workflows
• Design and implement a roadmap for regulatory operations improvement
• Best practices
• Internal SOPs
• Cross‑functional coordination models
• Support long‑term scalability of regulatory compliance function

Cross‑Functional Collaboration

• Work closely with:
• Scientific/laboratory teams (non‑regulatory background)
• Global Trade Compliance leadership
• Internal stakeholders across multiple business units
• Translate complex regulatory requirements into practical operational guidance
• Provide training and ongoing support to non‑regulatory personnel

Required Qualifications

Core Experience

• 5–10+ years of experience in:
• Regulatory affairs, regulatory operations, or trade compliance
• Supporting import/export of scientific, chemical, or biological materials
• Strong experience with Partner Government Agencies (PGAs), including:
• FDA
• Fish & Wildlife Service
• TSCA (Toxic Substances Control Act)
• Other applicable regulatory bodies

Technical Knowledge

• Deep understanding of:
• Regulatory requirements for non‑commercial / investigational materials
• Cross‑border shipment compliance in life sciences
• Ability to interpret and apply regulations in ambiguous or undefined scenarios

Functional Skills

• Experience building:
• SOPs
• Playbooks
• Regulatory frameworks from scratch
• Strong problem‑solving skills in unstructured environments