Senior Manager, Core Labeling Strategy

Alphapharm Pty Ltd T/A Viatris

Base: $95,000.00 - $193,000.00 usd; bonus/equity: ...
7-10 years of labeling experience
Development of global core labeling (ccds)
Experience with uspi and eu smpc
The role provides global regulatory labeling expertise to ensure product information is developed and maintained in compliance with applicable requirements

Job Summary

  • The role provides global regulatory labeling expertise to ensure product information is developed and maintained in compliance with applicable requirements.
  • Candidates will lead the development of Target Product Labeling and support major regulatory submissions like USPI and EU SmPC.
  • Viatris offers competitive salaries ranging from $95,000 to $193,000 USD along with an inclusive environment to make a global impact.

Matching Summary

The role provides global regulatory labeling expertise to ensure product information is developed and maintained in compliance with applicable requirements.

Salary

Base: $95,000.00 - $193,000.00 USD; Bonus/Equity: Not specified; Benefits: Competitive benefits package offered

Skills & Requirements

Must-have

  • 7-10 years of labeling experience
  • Development of global core labeling (CCDS)
  • Experience with USPI and EU SmPC
  • Regulatory submission support (NDA/BLA/MAA)
  • Cross-functional team leadership

Nice-to-have

  • Target Product Labelling (TPL) development
  • Competitive labeling benchmarking
  • Advanced degree in Science or Pharmacy
  • External forum representation skills
  • Innovative problem-solving approaches

Key Requirements

  • Bachelor's degree in Science, Medicine, or Pharmacy
  • 7-10 years of relevant labeling experience
  • Demonstrated experience with CCDS and territorial labeling
  • Ability to function autonomously in a matrixed environment

Work Rights

Not specified

Tailored Resume

Cover Letter