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Mirum Pharmaceuticals, a biopharmaceutical company focused on rare disease treatments, seeks a Senior Manager of Regulatory Affairs Labeling to lead global regulatory labeling strategy and documentation for marketed and development products.
In this role, you will create and maintain labeling content (CCDS, prescribing information, medication guides, patient information, package artwork) for US and international markets. You'll conduct competitive labeling research, develop project timelines, and manage labeling initiatives from inception through completion. You'll lead the Label Working Group, represent Regulatory Affairs in cross-functional meetings, and provide strategic regulatory guidance to internal stakeholders.
Key responsibilities include ensuring compliance with FDA, EU, and international health authority regulations; authoring or collaborating on regulatory submissions; liaising with external partners and international distributors; managing translation vendors; and serving as the primary expert resource for regulatory labeling advice across departments. You'll also coordinate with Supply Chain, Quality Assurance, and International Regulatory Affairs on global artwork development and implementation of commercial labeling updates.
You'll report to the Senior Director of Global Commercial Regulatory Affairs & Labeling and will partner with Medical Affairs, Legal, Clinical Development, Commercial teams, and international distributors.
Required: Bachelor's degree in a scientific discipline with 3–6 years of regulatory labeling experience in biopharmaceuticals. Experience writing and maintaining product labeling in US and EU markets is essential; global experience (LATAM, Middle East, Asia-Pacific) is desirable. You must demonstrate excellent written and verbal communication, ability to work independently and collaboratively, experience leading teams to project completion, and capability to critically review complex technical documents. Experience with Veeva Vault RIM and QualityDocs is desirable. You should be resilient, solution-oriented, operationally excellent, and able to manage multiple projects simultaneously under tight timelines.
