Manager of Regulatory Quality

Job Summary

To support vaccine development initiatives, the full-time Manager of Regulatory Quality will oversee project compliance with global regulatory standards, ensuring deliverables are completed on time and in submission-ready format while working remotely.

Key responsibilities

• Support and lead projects of varying complexity, ensuring regulatory compliance and quality standards are met
• Collaborate with cross-functional stakeholders to drive execution of regulatory deliverables
• Conduct quality reviews of regulatory documentation to ensure alignment with current guidance and internal standards

Required qualifications

• BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience
• Extensive knowledge of regulatory and quality assurance in the pharmaceutical or vaccine industry
• Strong understanding of global regulatory requirements and guidelines
• Proven project management experience within a regulatory or scientific setting
• Experience in reviewing regulatory documentation and analyzing scientific data for submissions