Senior Manager, Global Regulatory Labeling (Hybrid)

Regulatory Jobs; Foster City (CA); Hybrid; USD 175,000 - 195,000; Full time

Job summary

Mirum Pharmaceuticals, a biopharmaceutical company, seeks a Senior Manager, Regulatory Affairs Labeling to guide global labeling strategy and documents for marketed and development products. You will partner with Regulatory Affairs, Medical, Legal, Clinical Development, and International distributors, leading the Label Working Group and coordinating with cross-functional teams to ensure compliant labeling.

You will maintain regulatory labeling programs, oversee submissions, and ensure alignment

Qualifications

• Requires a scientific degree with 3–6 years of regulatory labeling experience in biopharma.
• Experience writing and maintaining US/EU labeling; global experience is a plus.
• Experience representing Regulatory Affairs Labeling on cross-functional teams.

Responsibilities

• Create and update labeling content for US and international regions (CCDS, prescribing information, patient leaflets, container labeling).
• Coordinate labeling projects from initiation to completion and manage timelines.
• Provide strategic regulatory guidance at labeling meetings and in cross-functional reviews.
• Lead the Label Working Group and internal approvals for labeling documents.
• Ensure compliance with local regulations and work with in-country resources as needed.
• Author or collaborate on regulatory submissions of labeling documents.
• Coordinate with translation vendors for foreign language labeling.
• Represent Global Regulatory Affairs on the Global Artwork Team and with Supply Chain.
• Assist International Regulatory Affairs in responding to health authorities on labeling questions.
• Maintain labeling archives and trackers; contribute to process improvements.

Skills

Regulatory labeling

Cross-functional leadership

Team leadership

FDA/EU labeling regulations

Veeva Vault RIM

QualityDocs

Regulatory guidance

Education

Bachelor’s or advanced degree in a scientific discipline

3–6 years regulatory labeling experience

Tools

Veeva Vault RIM

QualityDocs

Job description

Mirum Pharmaceuticals, a biopharmaceutical company, seeks a Senior Manager, Regulatory Affairs Labeling to guide global labeling strategy and documents for marketed and development products. You will partner with Regulatory Affairs, Medical, Legal, Clinical Development, and International distributors, leading the Label Working Group and coordinating with cross-functional teams to ensure compliant labeling.

You will maintain regulatory labeling programs, oversee submissions, and ensure alignment