Manager Regulatory Affairs

Job Summary

Representing Regulatory Affairs on cross-functional teams, the remote Manager, Regulatory Affairs CMC will manage the planning, compilation, quality control, and submission of Investigational Drug Applications (INDs) and Biologics License Applications (BLAs), ensuring high-quality documentation and compliance with regulatory standards.

Key responsibilities

• Manage the planning and submission of INDs, BLAs, and their amendments while ensuring timely approvals
• Provide regulatory expertise to cross-functional teams and interface with various stakeholders to develop CMC regulatory strategies
• Maintain logs of submissions and correspondence with regulatory agencies, while assisting in the development of project timelines and trackers

Required qualifications

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