Senior Manager/Manager, Global Regulatory Affairs CMC

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: Manager / Sr. Manager, Global Regulatory Affairs CMC 

This position reports to the Senior Director, Global Regulatory Affairs, CMC and will be responsible for planning and executing global CMC regulatory strategies, submissions and compliance activities for IND, initial marketing applications in the US and / or rest of the world and for supporting post approval compliance of assigned commercial products.

Preferred Location: Remote – US 

Essential Duties and Responsibilities*

• The role is responsible for preparing and tracking global regulatory CMC documents, submissions, and compliance activities for the US and Rest of World (RoW) and for supporting the communications with global business partners
• Oversee Clinical Trial Applications and initial marketing applications in RoW countries.
• Develop and prepare CMC documentation, acting as primary writer or coordinator.
• Interpret CMC regulatory requirements and develop strategies, including novel approaches.
• Assess risks and develop contingencies using technical and scientific knowledge.
• Contribute to CMC content in various non-CMC submissions (IBs, US PIs, SmPCs, Clinical Protocols, CSRs, etc.).
• Manage post-approval submissions (NDA Annual Reports, CBE-0, CBE-20, PAS, EU Type I and II Variations, Extension Applications, drug master files).
• Respond to Health Authority questions and requests.
• Request and prepare Health Authority meeting briefing documents.
• Work closely with Technical Operations team and external vendors collecting source documents, GMP certificates for CMC regulatory submissions 
• Represents GRA CMC on cross-functional project teams. Tracks the status of information requests to Contract Manufacturing Organizations (CMOs), CMC, QM, GRA, and other functions.  Coordinates the delivery of approved technical source documents and CMC information to business partners in accordance with project timelines
• Coordinate and manage global submissions (Annual Reports, CBE-0, CBE-30, PAS, Type IA/B and Type II Variations, Extension Applications, Change Management/Comparability Protocols).
• Support the GRA CMC team with Veeva™ RIM, Regulatory Commitments, and QMS/Change Control vaults.
• Manage assigned CMC programs, including day-to-day delivery, strategic activities, life cycle management teams, and compliance of commercial products.
• Develop and lead projects or team initiatives to support short-term operational goals.
• Contribute to the development of global regulatory initiatives.
• Perform additional duties and responsibilities as required.
• Able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives.

*additional duties and responsibilities not listed here may be required

Qualifications (Education & Experience)

• Minimum of a bachelor’s degree in chemistry or Pharmaceutical Sciences; a Master's degree is preferred.
• At least 5 years of experience as a regulatory CMC professional or in pharmaceutical science development/biopharmaceutical manufacturing/regulatory domain; or equivalent education and experience.
• Ability to interpret and apply global/regional CMC regulatory policies including FDA regulations, ICH requirements for assigned projects.
• Experience in IND submissions, regulatory interactions, authoring CMC sections, post-approval submissions in the US and preferably additional regions like EU, Canada, and RoW.
• Regulatory experience supporting small molecules and various solid oral dosage forms.
• Broad functional knowledge of pharmaceutical sciences/biopharmaceutical industry, with a clear understanding of drug development and commercial manufacturing of biopharmaceuticals.
• Technical and scientific understanding of biopharmaceutical drug development and commercial manufacturing with strong technical writing skills.
• Experience authoring Module 2 and 3 CMC sections for post-approval submissions.
• May serve as Subject Matter Expert (SME) in specific relevant disciplines or as a regulatory CMC resource for specialized pharmaceutical science projects.
• Competent in using computer-based systems such as Microsoft Office, PowerPoint, and electronic document management systems. Ability to learn and navigate tracking/change control systems, and willing to train and support others in system use.