Overview
Regulatory Compliance Manager Jobs in United States at Medasource
Title: Regulatory Compliance Manager
Company: Medasource
Location: United States
Job Title: Regulatory Compliance & Operations Program Manager – Preclinical Logistics (PGA Focus)
Location: Remote
Job Type: Contract
Pay Rate: $90–$100/hour
About the Role
We are seeking a Regulatory Compliance & Operations Program Manager to support the global movement of preclinical and investigational laboratory materials across international borders. This role focuses on navigating Partner Government Agency (PGA) regulatory requirements (e.g., FDA, Fish & Wildlife, TSCA) for non-commercial, early-stage materials that do not follow traditional product or supply chain structures.
The ideal candidate will thrive in an unstructured environment, partnering closely with scientific teams and global trade compliance leaders to establish regulatory frameworks, provide real-time guidance, and build scalable processes for compliant material movement.
Key Responsibilities
Regulatory Advisory & Execution
- Provide hands-on regulatory support for global shipments of preclinical and investigational materials
- Determine and advise on:
- Required permits, forms, and documentation
- Applicable Partner Government Agency (PGA) regulations (e.g., FDA, Fish & Wildlife, TSCA)
- When to escalate regulatory issues vs. resolving internally
- Partner with internal teams to:
- Ensure compliant import/export of laboratory materials
- Address real-time shipment issues and regulatory questions
- Serve as the primary regulatory resource for complex or non-standard lab-to-lab shipments
Process Development & Standardization
- Build regulatory guardrails and decision-making frameworks
- Develop a regulatory playbook outlining:
- Requirements by shipment type or scenario
- Agency-specific workflows
- Documentation standards
- Create repeatable processes for:
- Determining regulatory requirements
- Managing exceptions and edge cases
- Improve consistency across teams currently operating without formal regulatory structure
Program & Strategy Development
- Conduct an initial assessment of current regulatory gaps and workflows
- Design and implement a roadmap for regulatory operations improvements
- Establish:
- Internal SOPs
- Best practices
- Cross-functional coordination models
- Support the long-term scalability of the regulatory compliance function
Cross-Functional Collaboration
- Work closely with:
- Scientific and laboratory teams
- Global Trade Compliance leadership
- Internal stakeholders across multiple business units
- Translate complex regulatory requirements into practical operational guidance
- Provide training and ongoing regulatory support to non-regulatory personnel
Required Qualifications
Experience
- 5–10+ years of experience in:
- Regulatory affairs
- Regulatory operations
- Trade compliance
- Experience supporting import/export of scientific, chemical, or biological materials
- Strong experience working with Partner Government Agencies (PGAs) including:
- FDA
- Fish & Wildlife Service
- TSCA (Toxic Substances Control Act)
- Other relevant 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
- Regulatory playbooks
- Compliance frameworks from scratch
- Strong problem-solving skills in highly unstructured environments
- Ability to balance strategic planning with hands-on execution
Preferred Qualifications
- Background in chemistry, biology, or life sciences
- Experience working with:
- Preclinical or clinical trial materials
- Laboratory operations or scientific teams
