Associate Director, Global Regulatory Strategy

Biogen

Baar, Switzerland
Global and eu regulatory strategies
Lead regulatory submission process
Interface with regulatory authorities
The Associate Director, Global Regulatory Strategy will be responsible for developing and delivering innovative, breakthrough global and EU regulatory strategies for product development and approval, in alignment with the global business strategy

Job Summary

  • The Associate Director, Global Regulatory Strategy will be responsible for developing and delivering innovative, breakthrough global and EU regulatory strategies for product development and approval, in alignment with the global business strategy.
  • Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China).
  • As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.

Matching Summary

The Associate Director, Global Regulatory Strategy will be responsible for developing and delivering innovative, breakthrough global and EU regulatory strategies for product development and approval, in alignment with the global business strategy.

Skills & Requirements

Must-have

  • Global and EU regulatory strategies
  • Lead regulatory submission process
  • Interface with regulatory authorities
  • Develop Core Data Sheet
  • Assess regulatory risks

Nice-to-have

  • Collaborative leader
  • Cross-functional team guidance
  • Multicultural contexts
  • Senior stakeholder engagement

Key Requirements

  • Degree in Life Science or related discipline
  • Late-stage development regulatory experience
  • Global and EU regional regulatory lead experience
  • 8 years pharmaceutical/biotechnology industry experience
  • 6 years in Regulatory Affairs (Strategy)
  • Experience with clinical and pre-clinical regulatory aspects
  • Direct experience interfacing with FDA, EMA, and PMDA

Work Rights

Not specified

Tailored Resume

Cover Letter