Global CMC Regulatory Lead: Strategy & Submissions

Xerispharma; Chicago (IL); Hybrid; USD 155,750 - 213,600; Full time

Benefits offered by this job

Hybrid work model

Competitive compensation

Equity or long-term incentive awards

Paid time off benefits

Job summary

Xeris Pharmaceuticals, Inc. in Chicago, IL is seeking a Senior Manager of Global CMC Regulatory Affairs to lead regulatory development plans and drive successful execution across product pipelines.

You will represent the function on cross-functional initiatives and influence decision-making with internal and external stakeholders under tight timelines. The role requires at least 5 years in pharmaceutical CMC regulatory affairs, deep knowledge of US and global guidelines, and strong leadership,

Qualifications

• Minimum 5 years in pharmaceutical CMC regulatory affairs with global scope.
• In-depth knowledge of US and global CMC guidelines and regulations.
• Ability to influence cross-functional teams and external partners.

Responsibilities

• Serve as Global CMC regulatory leader for assigned products.
• Prepare global CMC content for INDs, NDAs, MAAs, and other filings.
• Develop and implement CMC regulatory strategies across development.
• Provide guidance to Technical Operations and Quality teams.
• Engage with regulatory agencies on CMC matters as requested.
• Create CMC submission timelines with cross-functional teams.
• Manage internal teams and external consultants to meet timelines.

Skills

Regulatory leadership

Negotiation

Teamwork

Attention to detail

Problem solving

Written & verbal communications

Analytical skills

Organizational skills

Education

B.S. in chemistry or pharma sciences

Job description

Xeris Pharmaceuticals, Inc. in Chicago, IL is seeking a Senior Manager of Global CMC Regulatory Affairs to lead regulatory development plans and drive successful execution across product pipelines.

You will represent the function on cross-functional initiatives and influence decision-making with internal and external stakeholders under tight timelines. The role requires at least 5 years in pharmaceutical CMC regulatory affairs, deep knowledge of US and global guidelines, and strong leadership,