Director of Regulatory Operations

Job Summary

Providing operational leadership for global regulatory submissions, the contract Director of Regulatory Operations will oversee teams and vendors while translating regulatory strategies into executable plans, all within a remote, four-month engagement.

Key responsibilities

• Provide operational leadership and accountability for global regulatory submissions across all application types
• Translate regulatory strategies into executable submission plans, timelines, and resource models
• 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 across multiple application types
• 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