Regulatory Strategy Lead, CMC for Small Molecules

Biopharma Careers; Durham (NC); Hybrid; USD 120,000 - 150,000; Full time

Job summary

GSK seeks a Regulatory Project Manager, Strategy—CMC RA Small Molecules Mature Products—to lead CMC regulatory strategy for marketed small molecule assets. You will prepare submissions, review regulatory content, and serve as the U.S.

regulatory contact, guiding cross-functional teams through lifecycle activities and ensuring compliance across global markets. This hybrid role requires strong communication, project leadership, and a deep understanding of U.S.

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.
• Direct experience preparing or contributing to CMC sections of regulatory submissions for the U.S. market.
• Six or more months experience with U.S. regulatory requirements and guidance relevant to CMC, including Good Manufacturing Practices.
• Advanced degree (Master's or PhD) in a relevant scientific field (preferred).
• Experience leading U.S. regulatory interactions and meeting preparation with the FDA.

Responsibilities

• Develop CMC strategy for CMC submission documents to support small molecule marketed product lifecycle management activities in accordance with applicable regulatory and scientific standards.
• Ensure information submitted for lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
• Prepare, review and quality-check CMC content for regulatory filings, post-approval variations, and maintenance submissions.
• Act as primary U.S. regulatory contact for agency interactions, written questions, and meeting preparation.
• Advise cross-functional teams on U.S. global CMC regulatory requirements and timelines to support supply continuity.
• Manage regulatory risk by identifying gaps, proposing mitigations, and coordinating actions with stakeholders.
• Ensure regulatory compliance is maintained and share best-practices and learnings within the CMC Regulatory teams and other impacted functions.
• Share CMC subject matter expertise and support continuous improvement of regulatory processes.

Skills

Communication

Digital Fluency

Influencing Without Authority

Learning Agility

Pharmaceutical Regulatory Compliance

Problem Solving

Regulatory Strategies

Strategic Leadership

Education

Bachelor's degree in pharmaceutical sciences or related

Advanced degree (Master's or PhD) preferred

Job description

GSK seeks a Regulatory Project Manager, Strategy—CMC RA Small Molecules Mature Products—to lead CMC regulatory strategy for marketed small molecule assets. You will prepare submissions, review regulatory content, and serve as the U.S.

regulatory contact, guiding cross-functional teams through lifecycle activities and ensuring compliance across global markets. This hybrid role requires strong communication, project leadership, and a deep understanding of U.S.