Regulatory Affairs Specialist

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

• 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).
• 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.
• 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.
• 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.

• 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.
• 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.
• 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.

• Background in chemistry, biology, or life sciences.
• Experience with preclinical or clinical trial materials.
• Familiarity with laboratory operations or scientific environments.
• Degree in a relevant field.

The position is remote with working hours from 8am to 5pm Eastern. It is a contingent role within the United States, focusing on regulatory and compliance operations in the medical and scientific sectors.

Job Type & Location

This is a Contract position based out of Richmond, VA.

The pay range for this position is $34.37 - $38.19/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on Jun 3, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $34 - $38