Job Summary

A biotechnology research company is in need of a Remote Global Submissions Operations Management Director.

Core Responsibilities of this position include:

• Responsible for functional resource/headcount planning
• Provide direction and recommendations on submission checklists, internal authoring standards, publishing timelines, and supporting tools
• Liaison to Health Authorities regarding electronic submission requirements

Required Skills:

• Business travel to be ~20% as required
• Minimum of 12 years’ Regulatory Operations experience in the pharmaceutical and biotechnology industry
• 6 years’ experience in a regulatory operations leadership role
• Must have experience and knowledge with CTD/eCTD and working knowledge of FDA, CFDA and ICH regulatory submission guidance and regulations
• Bachelor’s degree required; Master’s Degree preferred