What are the responsibilities and job description for the Director, Global Regulatory Operations position at ESPERION THERAPEUTICS INC?
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.
