Senior Regulatory Labeling Strategist

Mirum Pharmaceuticals; Foster City (CA); Hybrid; USD 175,000 - 195,000; Full time

Job summary

Mirum Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs Labeling to guide global labeling strategy for marketed and development products. You will partner with Regulatory, Medical, Legal, Clinical and International teams and lead the Label Working Group to ensure high-quality labeling across regions.

The role requires extensive regulatory labeling expertise, ability to lead cross-functional teams, and experience with US FDA and international labeling requirements.

Qualifications

• Bachelor’s or advanced degree in a scientific discipline with 3–6 years regulatory labeling experience.
• Experience writing and maintaining product labeling for US/EU; global labeling experience desirable.
• Experience representing Regulatory Affairs Labeling on cross-functional teams.

Responsibilities

• Create and update labeling content for programs in US and international regions including CCDS, prescribing information, medication guides, patient information/leaflet/IFU, package label artwork.
• Develop project timelines and manage labeling projects from initiation to completion.
• Lead Label Working Group and internal review/approval of labeling documents.
• Ensure labeling complies with local regulations by coordinating in-country resources.
• Author or collaborate on regulatory submissions of labeling documents.
• Coordinate with multidisciplinary teams for implementation of labeling updates.

Skills

Regulatory labeling

Cross-functional leadership

Project management

Regulatory guidance

Education

Science degree

Tools

Veeva Vault RIM

QualityDocs

Job description

Mirum Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs Labeling to guide global labeling strategy for marketed and development products. You will partner with Regulatory, Medical, Legal, Clinical and International teams and lead the Label Working Group to ensure high-quality labeling across regions.

The role requires extensive regulatory labeling expertise, ability to lead cross-functional teams, and experience with US FDA and international labeling requirements.