Senior CMC Regulatory Strategy Manager

Position Summary

You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities. You will work with cross‑functional teams across development, manufacturing, quality and regulatory to prepare submissions and respond to regulatory requests. Your work will directly support timely access to medicines and continued supply for patients.

Responsibilities

• Drive the CMC strategy, coordinate timely preparation and authorship of technical (CMC) regulatory documents, and identify risks to submission data and package, providing well‑defined mitigation strategies.
• Mentor or train staff; manage project activities for multiple complex projects and teams, providing strategic direction, data assessment and conclusions within and across departments.
• Engage and lead CMC Subject‑Matter‑Expert activities internally and externally to improve compliance, harmonisation and efficiency.
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Ready to Apply?

Submit your application today and join our talented team at 1925 GlaxoSmithKline LLC.