Director, Regulatory Operations

By | May 27, 2026

SimulStat

Remote, 4-month contract

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
Oversee teams and external vendors responsible for planning, preparing, publishing, submitting, and archiving global regulatory dossiers
Define, own, and maintain submissions-related SOPs, work instructions, job aids, and best practices to ensure consistent execution across programs and regions
Drive continuous improvement of submission processes to reduce cycle times, increase predictability, and improve quality
Ensure alignment of submission processes with Quality systems and inspection-readiness expectations
Partner with Medical Writing, Regulatory Affairs, Quality, Clinical Operations, and external partners to ensure seamless handoffs across the submission lifecycle
Provide operational guidance and training to cross-functional contributors involved in submissions
Advance cross-functional initiatives that support broader Regulatory Operations objectives
Lead, mentor, and develop a submissions-focused team

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, submission standards, and process improvement initiatives
Experience operating in a fast-paced, dynamic environment with evolving priorities
Proficiency in Smartsheet or similar project tracking tools preferred
Regulatory publishing capability; ability to serve as backup publisher a plus