Employer Industry:

Biotechnology

Why consider this job opportunity:Salary up to $242,300Eligible for annual bonus and equity awardsInclusive market-leading benefits including medical, dental, and vision coverageGenerous paid time off, including a week-long company shutdown in both Summer and WinterFlexible work options: fully remote, hybrid, or on-siteOpportunities for professional growth and development, including educational assistance programs

What to Expect (Job Responsibilities):Coordinate development of the Target Label Profile (TLP), Company Core Data Sheet (CCDS), and regional labels for pipeline programs/productsConduct research on labeling precedents, regulations, and policies to inform labeling strategyLead the Label Working Group (LWG) for assigned programs/products and represent the group at governance meetingsProvide strategic input for Health Authority interactions regarding labeling submissions and negotiationsCollaborate with cross-functional teams to ensure successful labeling outcomes

What is Required (Qualifications):Bachelor’s degreeTypically requires 8 years of experience in regulatory affairs focused on global labeling or a related disciplineProven ability to create development labeling from available resourcesStrong research skills to understand complex scientific and regulatory informationExcellent planning, prioritization, and teamwork abilities related to regulatory labeling

How to Stand Out (Preferred Qualifications):Experience in developing Instructions for Use (IFU) documentsPeople management experience

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