CMC Regulatory Strategy Lead – Small Molecules

GlaxoSmithKline; Durham (NC); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

GlaxoSmithKline (GSK) is seeking a Regulatory Project Manager, Strategy to provide CMC regulatory support for small molecule assets across global markets in a hybrid on-site role. Lead regulatory strategy, matrix governance, and lifecycle planning to ensure product readiness and compliance.

You will collaborate with manufacturing, quality, and regulatory teams to prepare variation dossiers, support agency interactions, and guide risk mitigation, enabling continuity of market supply and efficient

Qualifications

• Bachelor’s degree in pharmacy, chemistry, pharmaceutical sciences, or related scientific discipline, or equivalent experience.
• Minimum 2 years’ experience in CMC regulatory affairs focused on small molecules.
• Direct experience preparing CMC sections of US regulatory submissions.
• Experience with U.S. regulatory requirements and GMPs.

Responsibilities

• Develop CMC strategy for submission documents supporting lifecycle activities.
• Ensure lifecycle submissions meet regional regulatory requirements.
• Prepare and quality-check CMC content for filings and post-approval variations.
• Act as primary U.S. regulatory contact for agency interactions and meetings.
• Advise cross-functional teams on U.S. CMC regulatory requirements and timelines.
• Manage regulatory risk by identifying gaps and coordinating actions.

Skills

Regulatory strategy

CMC regulatory compliance

Communication

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in pharmacy/chemistry/pharmaceutical sciences

Advanced degree (Master's or PhD)

Job description

GlaxoSmithKline (GSK) is seeking a Regulatory Project Manager, Strategy to provide CMC regulatory support for small molecule assets across global markets in a hybrid on-site role. Lead regulatory strategy, matrix governance, and lifecycle planning to ensure product readiness and compliance.

You will collaborate with manufacturing, quality, and regulatory teams to prepare variation dossiers, support agency interactions, and guide risk mitigation, enabling continuity of market supply and efficient