Homeoffice Regulatory Ops: Senior Associate or Manager bei 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: Regulatory Operations – Senior Associate or Manager

We are seeking a motivated Regulatory Operations professional to join our team as either a Senior Associate or Manager, depending on experience. This role is responsible for end-to end submission publishing, planning and tracking across major and emerging markets, ensuring high quality and compliant submissions to global health authorities. The individual will work closely with cross-functional teams, support the use of regulatory systems, and contribute to process improvements. The Senior Associate or Manager, Regulatory Operations will report to the Director, Global Regulatory Operations.  This position is a remote, work from home opportunity.

The difference between levels will be based on experience, scope of responsibility, and leadership expectations.

Preferred Location: Remote – US 

Essential Duties and Responsibilities*

• As an integral member of Esperion’s regulatory operations team, provides oversight of regulatory publishing and submission support for global submissions, ensuring compliance with technical and regulatory standards.
• Responsible for compiling, publishing QC, and validating of electronic submissions with no technical errors in accordance with health authority requirements and established timelines.
• Manage delivery of regulatory submissions, including major submissions (INDs, NDAs, sNDA) and routine/maintenance submissions (supplements, amendments, periodic reports).
• Provide project management support for larger, more complex submissions to ensure cross-functional alignment and timely delivery. 
• Manage and track incoming health authority correspondence to ensure timely assessment, assignment, and response.
• Collaborate with submission content contributors, regulatory leads, and project management in the planning and preparation of submission components.
• Maintain submission tracking tools to promote transparency regarding progress and status of all submission projects.   
• Perform MS Word document formatting using Starting Point Template (or similar) for assigned projects.
• Support process improvement activities and implementation of new technology solutions for Regulatory.
• Maintain proficiency and expertise with electronic Common Technical Document (eCTD) publishing requirements and regulations associated with global regulatory submissions.
• Support or Oversee SPL submissions.
• Provide 1st tier support for Veeva RIM system and ensure optimal use of Veeva Vault.
• Maintain best practices and assists with development of assigned regulatory operations initiatives and Standard Operating Procedures (SOP)/Work Instructions (WI).
• Provides support to Regulatory Affairs team for product/project related activities such as Veeva Vault, regulatory systems, and other activities as needed.

*additional duties and responsibilities as assigned

Level Differentiation

Senior Associate, Regulatory Operations

• Manages assigned projects independently with oversight
• Provides technical expertise in document formatting and publishing tools.
• 3 – 5 years of Regulatory Operations experience.

Manager, Regulatory Operations

• Mentors, trains, and guides junior team members.
• Represents Regulatory Operations in cross-functional forums and process improvement initiatives.
• 6+ years of Regulatory Operations experience, including leadership responsibility.

Qualifications (Education & Experience)

• College degree and experience performing regulatory operations activities in the pharmaceutical and/or biotechnology industries, OR equivalent education and experience.
• Advanced knowledge of Microsoft Word, Adobe Acrobat, Veeva Vault electronic document management systems (strongly preferred), document authoring templates (ie, Accenture StartingPoint), document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required. 
• Hands-on operation of eCTD publishing tools, systems and software are required. (DocuBridge experience strongly preferred).
• In-depth understanding of global health authority requirements and submission standards across major and emerging markets.
• Prior experience with successful NDA and MAA submissions.
• Detail-oriented with ability and desire to work in a fast paced, team-oriented environment with the ability to manage simultaneous priorities and challenging deadlines.
• Excellent communication and organizational skills with the ability to self-manage and meet deadlines.