CMC Regulatory Strategy Lead, Small Molecules

GlaxoSmithKline; Durham (NC); Hybrid; USD 120,000 - 180,000; Full time

Job summary

GlaxoSmithKline is seeking a Regulatory Manager, Strategy to provide CMC support for a portfolio of marketed drug substances and products. The role offers involvement in global regulatory strategies, authoring variation dossiers, and ensuring readiness for regulatory agency questions to maintain market supply.

The position collaborates with manufacturing, quality, and development teams, focusing on lifecycle management and regulatory compliance for U.S. and global markets.

Qualifications

• Bachelor’s degree or equivalent in a scientific discipline.
• 2+ years in CMC regulatory affairs focused on small molecules, lifecycle management and post-approval activities.
• Direct experience preparing or contributing to CMC sections of U.S. regulatory submissions.
• 6+ months experience with U.S. regulatory requirements and guidance related to CMC, including GMPs.

Responsibilities

• Develop CMC strategy for submission documents to support small molecule lifecycle management.
• Ensure lifecycle submissions meet regional requirements for regulatory flexibility.
• 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 prep.
• Advise cross-functional teams on U.S. CMC requirements and timelines to support supply continuity.
• Manage regulatory risk by identifying gaps and coordinating actions with stakeholders.
• Share CMC expertise and support process improvements across teams.

Skills

CMC Regulatory

Regulatory Strategy

Regulatory submissions

FDA interactions

Cross-functional collaboration

Regulatory compliance

Education

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

Advanced degree (Master’s or PhD)

Job description

GlaxoSmithKline is seeking a Regulatory Manager, Strategy to provide CMC support for a portfolio of marketed drug substances and products. The role offers involvement in global regulatory strategies, authoring variation dossiers, and ensuring readiness for regulatory agency questions to maintain market supply.

The position collaborates with manufacturing, quality, and development teams, focusing on lifecycle management and regulatory compliance for U.S. and global markets.