Regulatory Compliance Specialist

Responsibilities

• Ensure full compliance with federal, state, and international regulations governing pharmaceutical and cold chain logistics, including biologics and vaccines.
• Support the implementation, maintenance, and continuous improvement of Quality Management System (QMS) procedures related to regulatory compliance.
• Review, create, and maintain SOPs, policies, and quality agreements to ensure alignment with current regulatory requirements.
• Conduct regulatory research to identify changes in laws, guidelines, and industry best practices affecting pharmaceutical storage and distribution.
• Partner with operations, warehouse, and quality teams to ensure adherence to GDP, cGMP, FDA standards, and temperature-controlled handling requirements.
• Assist in internal audits, client audits, and regulatory inspections; track and support completion of corrective and preventive actions (CAPA).
• Evaluate and approve regulatory documentation for new products, shipping processes, and vendor compliance.
• Provide training and guidance to associates on regulatory requirements and compliance best practices.
• Maintain accurate and timely records to support audit readiness and regulatory submissions.
• Contribute to continuous improvement initiatives across regulatory processes and compliance programs.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Pharmacy, or a related field.
• 3–5 years of regulatory compliance experience within pharmaceutical, biotech, or 3PL logistics environments.
• Strong knowledge of cGMP, GDP, FDA, ICH, and other applicable pharmaceutical regulations.
• Experience with cold chain logistics for biologics and vaccines (preferred but not required).
• Ability to interpret and apply regulations to warehouse, storage, and distribution operations.
• Excellent organizational, communication, and problem-solving skills.
• Proficiency with Quality Management System (QMS) software and MS Office applications.
• Experience managing regulatory audits and inspections for both pharmaceuticals and biologics.
• Knowledge of ISO standards or other quality frameworks relevant to pharmaceutical logistics.
• Familiarity with temperature-sensitive product handling, validation protocols, and risk-management practices.
• Prior experience supporting client regulatory inquiries or submissions.