Director, Global Regulatory Operations

Company Overview

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.  

Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI.  The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Director, Global Regulatory Operations (Submissions, Publishing and Management)

Preferred Location: Remote – US 

Essential Duties and Responsibilities*

• Establish and execute Regulatory Operations strategies aligned with company goals.
• Oversee submission planning, management, and timely delivery of regulatory dossiers.
• Lead and develop the Regulatory Operations team, ensuring global execution of submission plans.
• Serve as the primary Regulatory Operations Lead, collaborating with Regulatory Strategy to develop and manage submission timelines and processes.
• Establish, train, and implement submission processes with internal teams and external partners.
• Develop, review, and approve Regulatory Operations SOPs and governing documents.
• Track submission timelines and ensure clear communication across global programs.
• Oversee global submission preparation, timelines, distribution, and archiving, ensuring compliance with regulatory standards.
• Manage and support Veeva platforms as needed.
• Serve as Submissions Manager for projects across the USA, EU, and other regions, collaborating on strategy and content planning.
• Train staff and serve as SME on regulatory systems, processes, and requirements.
• Liaise with global regulatory CRO teams to ensure complete CTA packages and submissions.
• Identify and troubleshoot regulatory gaps, conflicts, or process delays.
• Manage document collection and respond to CRO requests related to submissions.
• Oversee vendors handling submission publishing activities.
• Review and approve regulatory forms, correspondence, and study documentation for submission packages.
• Ensure completeness of global site study start-up packages.
• Conduct routine quality checks and audits to maintain compliance with SOPs and best practices.
• Manage the Regulatory Operations budget, vendor contracts, and invoice approvals.
• Lead cross-functional meetings on submission planning for clinical, non-clinical, and CMC programs.
• Coordinate with contract medical writers and SMEs on regulatory submission documents (e.g., RTQs).
• Serve as a backup regulatory contact for agency interactions as needed.
• Manage contractors for large eCTD application projects (e.g., NDA).

*additional duties and responsibilities as assigned

Qualifications (Education & Experience)

• Bachelor’s degree in a scientific discipline required; advanced degree preferred and a minimum of 10 years in Regulatory Operations, Submissions Management, or related roles involving regulatory interpretation and eCTD submission compilation and 6 years of direct management experience.
• Strong experience with USA and EU submissions across multiple submission types.
• Expertise in global eCTD standards and submission formats, with proficiency in publishing platforms (e.g., DocuBridge) and document management systems (e.g., Veeva).
• High familiarity with FDA CFR, regulatory guidance interpretation, and tracking regulatory changes impacting submissions.
• Strong organizational skills with the ability to manage multiple large-scale projects simultaneously.
• Ability to work in a fast-paced, dynamic environment, handling aggressive timelines while maintaining composure under pressure.
• Strong analytical skills with a high level of integrity in managing proprietary and confidential information.
• Prior experience managing regulatory affairs staff is a plus.