Manager of Regulatory Affairs

Job Summary

Representing Regulatory Affairs on cross-functional teams, the full-time Manager of Regulatory Affairs will manage the planning, compilation, quality control, and submission of Investigational Drug Applications (INDs) and Biologics License Applications (BLAs) while working remotely.

Key responsibilities

• Manage the planning and submission of INDs, BLAs, and amendments, ensuring high-quality documents are approved on schedule
• Provide regulatory expertise to cross-functional teams and assist in developing Gantt charts and trackers for submissions
• Maintain logs of submissions and correspondence with regulatory agencies, adhering to company standards and policies

Required qualifications

• BA/BS degree in a related field required
• 8+ years of experience in regulatory affairs or related functions in drug/biologic development
• Experience managing regulatory submissions to global health authorities in eCTD format
• Broad understanding of international regulations and procedures in drug/biologics development
• Advanced skills in Microsoft Office Suite and Adobe Acrobat Pro