Manager, Regional Regulatory Strategist

Moderna

London, United Kingdom
Remote
Regulatory strategy for eu and international markets
Regulatory submissions management
Health authority interactions (ema)
You will play a critical role in advancing the global regulatory path for Moderna’s mRNA programs in the European Union and international markets

Job Summary

  • You will play a critical role in advancing the global regulatory path for Moderna’s mRNA programs in the European Union and international markets.
  • Your key responsibilities will include supporting the development and execution of regulatory strategy and preparing and contributing to regulatory submissions.
  • Moderna offers best-in-class healthcare, a holistic approach to well-being, family building benefits, and generous paid time off.

Matching Summary

You will play a critical role in advancing the global regulatory path for Moderna’s mRNA programs in the European Union and international markets.

Skills & Requirements

Must-have

  • Regulatory strategy for EU and international markets
  • Regulatory submissions management
  • Health authority interactions (EMA)
  • mRNA regulatory pathways
  • Cross-functional team collaboration

Nice-to-have

  • Questioning convention
  • Digitizing workflows
  • Proactive risk mitigation

Key Requirements

  • 5+ years pharmaceutical industry experience
  • 3+ years Regulatory strategy experience
  • Experience with CTD format
  • Knowledge of EU regulatory procedures
  • Advanced degree preferred (PharmD, MSc, PhD)

Work Rights

Not specified

Tailored Resume

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