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Associate Director Regulatory Affairs, Labeling
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- BioPhase specializes in recruiting top talented professionals for the San Diego County Scientific community.
- Develop draft labeling text (such as USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and updates of approved package inserts for product lifecycle management.
- Assist in implementing a labeling review and approval process, documenting label history, LMT/ELC decisions, and CCDS exceptions to facilitate a seamless global labeling process.
- Ensure alignment of labeling strategy with overall regulatory and program strategy by collaborating with internal stakeholders including Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, and Supply Chain.
- Lead cross-functional labeling forums and meetings, such as LMT, to support draft label development.
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