Senior Director, GRA 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: Senior Director, Global Regulatory Affairs - Chemistry Manufacturing Controls (CMC)

The Senior Director of Global Regulatory Affairs will be responsible for the design, preparation and execution of global regulatory strategies in support of our drug development and post-approval lifecycle programs. Available as a remote position from a home-based office.

Preferred Location: Remote - US

Essential Duties and Responsibilities*

• Provide leadership for Global Regulatory Affairs (GRA) CMC, overseeing strategy development and execution.
• Manage and develop the GRA CMC team to ensure timely and effective regulatory support for investigational and commercial products.
• Develop and implement global and regional CMC regulatory strategies, assessing risks and mitigation plans in alignment with Health Authority requirements.
• Serve as the GRA CMC representative in cross-functional teams for Technical Operations (Tech Ops) and Quality Management (QM) or delegate as needed.
• Oversee the planning, preparation, and approval of high-quality regulatory CMC submissions across all development phases and lifecycle management.
• Lead or delegate document development, coordinating comment resolution meetings as needed.
• Engage in successful interactions and negotiations with global Health Authorities, ensuring compliance with commitments and deadlines.
• Collaborate with Alliance Management and Tech Ops to align post-approval CMC change strategies with business partners per licensing, supply, and quality agreements.
• Stay updated on global regulatory changes, advising teams on compliance and impact assessments.
• Ensure timely delivery of CMC programs, project plans, and strategic initiatives.
• Build and maintain strong relationships with internal and external stakeholders.
• Contribute to corporate and departmental policies, processes, and procedures to enhance performance and regulatory alignment.
• Provide regulatory due diligence and strategic advice as needed.

*additional duties and responsibilities as assigned

Qualifications (Education & Experience)

• Bachelor's degree in health/life sciences (e.g., Chemistry, Pharmacy, Biology) required; Advanced degree preferred and a minimum of 12 years in global regulatory CMC within pharmaceutical development or biopharmaceutical manufacturing, with strong technical leadership and 8 years of direct management experience.
• Preferred experience with small molecules, including solid oral dosage forms, oral solutions, suspensions, and immediate-/modified-release products.
• Proven ability to develop and implement complex CMC regulatory strategies, assess risks, and execute mitigation plans.
• Experience leading successful engagements with local and global regulatory agencies.
• Deep understanding of regional/global CMC regulations and their application to regulatory submissions for development, marketing applications, and lifecycle management.
• Extensive experience in authoring and reviewing CMC content for regulatory submissions.
• Strong experience building, leading, and developing high-performing Regulatory CMC or CMC authoring teams.
• Demonstrated leadership in cross-functional collaboration, problem-solving, and decision-making, with a proven track record of influencing multidisciplinary teams.
• Strong analytical, interpretive, and technical writing abilities; excellent verbal and written communication.
• Proficient in Microsoft Office (Word, Excel, PowerPoint) and electronic document management systems.
• Willingness to travel domestically and internationally as needed.