Biorepository Regulatory Technician IV

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.