Director, Regulatory Operations, Submissions

SimulStat Incorporated; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

SimulStat Incorporated seeks a seasoned Regulatory Operations leader to drive global regulatory submissions across all application types, translating strategies into executable plans, timelines, and resource models.

You will oversee teams and external vendors, define and maintain SOPs, and champion continuous improvement to shorten cycle times, boost predictability, and ensure inspection readiness across programs and regions.

Qualifications

• Senior regulatory operations or submissions leadership experience in pharmaceutical/biotech.
• Deep knowledge of global regulatory submissions processes 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 improvements.
• Experience in a fast-paced, dynamic environment with evolving priorities.
• Proficiency with project tracking tools (Smartsheet preferred).
• Regulatory publishing capability; ability to serve as backup publisher is a plus.

Responsibilities

• Provide operational leadership 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 SOPs, work instructions, job aids, and best practices for consistent execution.
• 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 for seamless handoffs.
• 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.

Skills

Regulatory leadership

Global submissions

eCTD knowledge

SOP development

Process improvement

Smartsheet

Tools

Smartsheet

Job description

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