Senior Manager of Regulatory Operations

Job Summary

A company is looking for a Senior Manager, Regulatory Operations.

Key Responsibilities

• Manage all Regulatory Affairs activities for health authority submissions, including compilation, publishing, and archiving
• Oversee external publishing staff and ensure compliance with submission standards and timelines
• Train project teams on regulatory requirements and coordinate with departments on regulatory documentation

Required Qualifications

• Bachelor's degree preferred or equivalent experience
• 8-12 years of relevant experience in the biotech or pharmaceutical industry (6-8 years with a Master's)
• Experience in a high-volume document production environment
• Expert knowledge of regulatory submission publishing standards and procedures
• Robust understanding of FDA and health agency regulations governing submission content and format