Core Labeling Lead

alvotech.is

Us and eu labeling expertise
Labeling strategy development
Regulatory labeling subject-matter expert
Act as the Regulatory Labeling subject‑matter expert for US and EU labeling, advising on authority requirements, internal processes, and standards

Job Summary

  • Act as the Regulatory Labeling subject‑matter expert for US and EU labeling, advising on authority requirements, internal processes, and standards.
  • Line manage and support Regulatory Labeling Leads (RLLs), fostering collaboration and development.
  • We are passionate about improving lives by increasing access to affordable biologics.

Matching Summary

Act as the Regulatory Labeling subject‑matter expert for US and EU labeling, advising on authority requirements, internal processes, and standards.

Skills & Requirements

Must-have

  • US and EU labeling expertise
  • Labeling strategy development
  • Regulatory labeling subject-matter expert
  • Lead labeling meetings
  • Veeva RIM / Veeva Quality experience

Nice-to-have

  • Fostering collaboration and development
  • Agile environment
  • Curiosity, ingenuity and simplicity

Key Requirements

  • 5+ years of experience in regulatory labeling
  • Bachelor’s degree in a relevant field
  • USPI authoring and EU MAA submissions experience
  • Readability User Testing experience
  • Document management and change control processes

Work Rights

Not specified

Tailored Resume

Cover Letter