Global CMC Regulatory Affairs Lead

Xeris Pharmaceuticals Inc; Georgia; Hybrid; USD 134,000 - 214,000; Full time

Benefits offered by this job

Equity or long-term incentive awards

Annual bonus

401(k) retirement benefits

Comprehensive benefits package

Job summary

Xeris Pharmaceuticals Inc. is seeking a Senior Manager of CMC Regulatory Affairs to drive global CMC strategy and manage regulatory submissions across INDs, NDAs, MAAs, and CTAs. The role requires coordinating with Technical Operations, Quality, and external partners to ensure compliant, timely deliverables.

The position is hybrid, based in the Chicago area with travel as needed and a base salary range of $133,500–$213,600, reflecting market norms for senior regulatory leadership in biopharma.

Qualifications

• Minimum of 5 years in the pharmaceutical industry with 5 years in CMC regulatory affairs.
• International experience preferred.
• In-depth knowledge of US and global CMC guidelines and regulations.

Responsibilities

• Lead as Global CMC regulatory leader for assigned products and prepare global CMC content for regulatory filings.
• Develop CMC regulatory strategies for integrated development plans and cross-functional alignment.
• Provide regulatory expertise to Technical Operations and Quality teams and review technical documentation.
• Engage with regulatory agencies on CMC matters and drive cross-functional decision making.
• Create submission timelines with cross-functional teams and manage internal/external resources.

Skills

Functional Leadership

Negotiation

Teamwork

Attention to Detail

Self-Starter

Problem Solving

Organizational Skills

Adaptability

Professionalism

Communication

Analytical Skills

Education

B.S. in a scientific discipline

Job description

Xeris Pharmaceuticals Inc. is seeking a Senior Manager of CMC Regulatory Affairs to drive global CMC strategy and manage regulatory submissions across INDs, NDAs, MAAs, and CTAs. The role requires coordinating with Technical Operations, Quality, and external partners to ensure compliant, timely deliverables.

The position is hybrid, based in the Chicago area with travel as needed and a base salary range of $133,500–$213,600, reflecting market norms for senior regulatory leadership in biopharma.