Job Description

Job Description

Job Description

Regulatory Laboratory Manager

Job Description

We are seeking a dedicated Regulatory Laboratory Manager to lead our team in managing lab documentation and ensuring global regulatory compliance. This role involves overseeing a fast-paced, high-volume lab environment and requires a strong understanding of regulatory affairs and sample management.

Responsibilities

• Manage lab documentation for samples in compliance with global regulatory standards.
• Guide and support Specialists and Coordinators to ensure the accurate and timely delivery of samples.
• Efficiently manage daily and weekly workloads and order entry processes.
• Develop leadership and management skills, participate in annual reviews, quality training, and other managerial duties.
• Determine, utilize, and manage necessary resources effectively.
• Develop and maintain record-keeping policies to support regulatory audit criteria requirements.
• Review, audit, and ensure quality control of documents and reports.
• Provide timely responses to regulatory requests and notices.
• Provide training in global compliance for regulations.
• Maintain a safe working environment and support EH&S compliance.
• Act as a liaison with regulatory agencies such as CBP, DOT, IATA, FDA, and USDA.
• Complete all necessary training and certifications.
• Support with sample handling and regulatory compliance.

Essential Skills

• Bachelor's Degree in Biology or related field.
• Minimum of 5 years related lab experience with 4 years in a regulatory environment.
• Proficient with MS Office, Teams, NetSuite Oracle, and ERP Systems.
• Excellent data entry and typing skills.
• Outstanding written and verbal communication skills.
• Strong organizational skills and attention to detail.
• Ability to perform tasks accurately and solve problems effectively.
• Experience handling biological materials and specimens.

Pay and Benefits

The pay range for this position is $25.00 - $30.00/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)

Workplace Type

This is a fully onsite position in Piscataway,NJ.

Application Deadline

This position is anticipated to close on Nov 7, 2025.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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