Global CMC Regulatory Lead: Strategy & Execution

Xeris Pharmaceuticals, Inc.; Chicago (IL); Hybrid; USD 134,000 - 214,000; Full time

Job summary

Xeris Pharmaceuticals, Inc. is seeking a Senior Manager of Global CMC Regulatory Affairs to lead regulatory strategy for CMC programs and drive cross-functional alignment across US and global programs.

The role emphasizes timely submissions, regulatory engagement, and influence with stakeholders. The position requires a BS in a scientific discipline, at least 5 years of pharma experience with dedicated CMC regulatory affairs, and strong leadership to guide teams, ensure timelines, and support

Qualifications

• B.S. in a scientific discipline required; B.S. in chemistry, pharmaceutical sciences or similar preferred.

Responsibilities

• Serve as Global CMC regulatory lead for assigned products.
• Prepare Global CMC content for INDs, NDAs, MAAs, IMPDs, CTAs, annual reports, and other regulatory documents.
• Develop and implement CMC regulatory strategy for integrated development plans and cross-functional programs.
• Provide regulatory guidance to Technical Operations and Quality teams.
• Review and approve technical documentation.
• Support clinical trial supply for local and global trials.
• Engage with regulatory agencies on CMC matters as needed.
• Identify regulatory issues and provide strategies to address them within cross-functional teams.
• Create submission timelines with cross-functional collaboration.
• Manage internal teams and external vendors to CMC timelines.

Skills

Cross-functional leadership

Negotiation

Attention to detail

Problem solving

Organizational skills

Written and verbal communication

Analytical skills

Education

B.S. in Chemistry/Pharmaceutical Sciences

Job description

Xeris Pharmaceuticals, Inc. is seeking a Senior Manager of Global CMC Regulatory Affairs to lead regulatory strategy for CMC programs and drive cross-functional alignment across US and global programs.

The role emphasizes timely submissions, regulatory engagement, and influence with stakeholders. The position requires a BS in a scientific discipline, at least 5 years of pharma experience with dedicated CMC regulatory affairs, and strong leadership to guide teams, ensure timelines, and support