Manager, Regulatory Affairs

Responsibilities

• Manage the planning, compilation, QC, and submission of INDs, BLAs, and amendments
• Prepare routine IND and CTA amendments
• Work with submission authors and reviewers to ensure high-quality, on-schedule documentation
• Provide regulatory expertise to cross-functional teams
• Assist in developing and managing Gantt charts and submission trackers
• Maintain logs of IND and CTA submissions and agency correspondence
• Prepare submission templates and shells based on company standards

Requirements

• BA/BS degree in a related field
• 8+ years of experience in regulatory affairs for drug/biologic development (or 6+ years with a Master's, or 4+ years with a PhD)
• Experience managing regulatory submissions in eCTD format for global health authorities
• Broad understanding of international regulations, ICH, and regional requirements
• Proficiency in Microsoft Of...