Director of Regulatory Operations

Job Summary

Providing operational leadership, the full-time Director of Regulatory Operations will manage global regulatory submissions, translating strategies into executable plans while overseeing teams and external vendors in a remote environment.

Key responsibilities

• Provide operational leadership for global regulatory submissions across all application types
• Oversee teams and external vendors in planning, preparing, and submitting global regulatory dossiers
• Drive continuous improvement of submission processes to enhance quality and reduce cycle times

Required qualifications

• Demonstrated experience in a senior regulatory operations or submissions leadership role within the pharmaceutical or biotechnology industry
• Deep working knowledge of global regulatory submissions processes and requirements
• Experience overseeing regulatory publishing and managing external submission vendors
• Strong understanding of eCTD standards and submission lifecycle management
• Proven ability to develop and implement SOPs and process improvement initiatives