CMC Regulatory Strategy Lead – Small Molecules

GlaxoSmithKline; Durham (NC); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

GlaxoSmithKline is seeking a Regulatory Project Manager, Strategy for CMC RA Small Molecules Mature Products. The role provides strategic regulatory support across marketed products, with emphasis on US regulatory interactions and lifecycle management.

You will partner with manufacturing and quality to ensure compliant, timely submissions and product continuity. Qualifications include a chemistry/pharmacy/biopharma background with 2+ years in CMC regulatory affairs and experience with US

Qualifications

• Bachelor’s degree in pharmacy, chemistry, pharmaceutical sciences, or related scientific discipline, or equivalent experience.
• Minimum of 2 years’ experience in CMC regulatory affairs focused on small molecules, including lifecycle management and post-approval activities.
• Six or more months experience with U.S. regulatory requirements and guidance relevant to CMC, including GMP.

Responsibilities

• Develop CMC strategy for submission documents to support small molecule lifecycle management.
• Prepare, review and quality-check CMC content for regulatory filings and post-approval variations.
• Act as primary U.S. regulatory contact for agency interactions and meeting preparation.
• Advise cross-functional teams on U.S. CMC regulatory requirements and timelines.
• Manage regulatory risk by identifying gaps and coordinating actions with stakeholders.

Skills

Communication

Digital Fluency

Influencing Without Authority

Learning Agility

Pharmaceutical Regulatory Compliance

Problem Solving

Regulatory Strategies

Strategic Leadership

Education

Bachelor’s degree in pharmacy, chemistry, pharmaceutical sciences, or related scientific discipline

Advanced degree (Master’s or PhD) in a relevant scientific field

Job description

GlaxoSmithKline is seeking a Regulatory Project Manager, Strategy for CMC RA Small Molecules Mature Products. The role provides strategic regulatory support across marketed products, with emphasis on US regulatory interactions and lifecycle management.

You will partner with manufacturing and quality to ensure compliant, timely submissions and product continuity. Qualifications include a chemistry/pharmacy/biopharma background with 2+ years in CMC regulatory affairs and experience with US