Senior Regulatory Labeling Lead for Global Markets

Mirum Pharmaceuticals, Inc.; Foster City (CA); Sur place; USD 175 000 - 195 000; Plein temps

Résumé du poste

Mirum Pharmaceuticals, Inc. is seeking a Senior Manager, Regulatory Affairs Labeling to lead global labeling strategy and documentation for marketed and development products.

You will partner with Regulatory Affairs, Medical Affairs, Legal, Clinical Development, Commercial, and distributors, leading the Label Working Group and guiding internal reviews. The role requires directing labeling content creation, ensuring compliance with FDA, EU, and international requirements, and coordinating

Qualifications

• 3–6 years of regulatory labeling experience in biopharma.
• Experience writing, developing, maintaining US/EU labeling; global exposure is desirable.
• Experience representing Regulatory Affairs Labeling on cross-functional teams.

Responsabilités

• Create and update labeling content for US and international regions including CCDS, prescribing information, labeling documents, and artwork.
• Lead Label Working Group and coordinate internal reviews and approvals.
• Ensure labeling compliance with FDA, EU, and international regulations; work with local resources as needed.
• Collaborate with translation vendors and international partners in labeling projects.
• Coordinate labeling projects from initiation to completion and manage timelines.
• Represent regulatory labeling in cross-functional meetings and provide strategic regulatory guidance.

Connaissances

Regulatory labeling

Leadership

Cross-functional collaboration

Project management

Attention to detail

Formation

Bachelor's degree in a scientific discipline

Outils

Veeva Vault RIM

QualityDocs

Description du poste

Mirum Pharmaceuticals, Inc. is seeking a Senior Manager, Regulatory Affairs Labeling to lead global labeling strategy and documentation for marketed and development products.

You will partner with Regulatory Affairs, Medical Affairs, Legal, Clinical Development, Commercial, and distributors, leading the Label Working Group and guiding internal reviews. The role requires directing labeling content creation, ensuring compliance with FDA, EU, and international requirements, and coordinating