CMC Regulatory Strategy Lead – Global Vaccines

GlaxoSmithKline; Boston (MA); On-site; USD 104,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Long term incentive program

Health care and other insurance

Job summary

GlaxoSmithKline is seeking a senior CMC regulatory lead to oversee global regulatory activities for investigational, late-phase, and early commercial products in the United States. The role requires coordinating CMC strategy and submissions from IND/IMPD through NDA/BLA and lifecycle management, with cross-functional collaboration to ensure timely approvals.

You will advise teams on global CMC requirements, drive continuous process improvements, and support major inspections with managerial

Qualifications

• Subject matter expert in CMC regulatory affairs.
• Experience with IND/IMPD/NDA submissions across development stages.
• Strong communication and project management skills.

Responsibilities

• Lead global CMC regulatory activities for assigned projects.
• Develop CMC submission strategies across development stages.
• Advise teams on worldwide CMC regulations and guidelines.
• Support inspections and regulatory interactions.

Skills

Regulatory affairs

CMC regulatory

Global regulatory strategy

Project leadership

Education

BSc Life sciences

PhD

Job description

GlaxoSmithKline is seeking a senior CMC regulatory lead to oversee global regulatory activities for investigational, late-phase, and early commercial products in the United States. The role requires coordinating CMC strategy and submissions from IND/IMPD through NDA/BLA and lifecycle management, with cross-functional collaboration to ensure timely approvals.

You will advise teams on global CMC requirements, drive continuous process improvements, and support major inspections with managerial