Regulatory Implementation Labeling Lead

alvotech.is

Commercial labeling implementation
Labeling lifecycle management
Fda and ema labeling regulations
Own and manage Change Controls for labeling text and artwork for commercial products where Alvotech is MAH

Job Summary

  • Own and manage Change Controls for labeling text and artwork for commercial products where Alvotech is MAH.
  • Independently manage labeling development projects for submissions to EU Notified Bodies, FDA DMEPA, and EMA.
  • Alvotech is purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity.

Matching Summary

Own and manage Change Controls for labeling text and artwork for commercial products where Alvotech is MAH.

Skills & Requirements

Must-have

  • Commercial labeling implementation
  • Labeling lifecycle management
  • FDA and EMA labeling regulations
  • Veeva Vault experience
  • Change control management
  • Structured Product Labeling (SPL)

Nice-to-have

  • Cross-functional collaboration
  • Agile environment
  • Purpose-driven culture
  • Curiosity and ingenuity

Key Requirements

  • 6+ years of experience in regulatory labeling
  • Bachelor's degree
  • Experience with labeling tools and systems
  • Experience with text comparison software

Work Rights

Not specified

Tailored Resume

Cover Letter