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Biosimilar Global Regulatory Lead REF 1066

We are looking for a consultant who has global experience leading submissions; ideally a Biosimilar expert

Duties will include

  • ad-hoc requests and support for Biosimilars (US and EU primarily)
  • Regulatory CMC project management
  • Operational support to prepare and submit regulatory submissions and briefing documents
  • Regulatory CMC technical writing
    • authoring regulatory applications based on available source reports Commercial GRL
    • experience leading a commercial/approved product registered globally.
    • Modality agnostic but preferable to have experience in biologics.
  • Contract Type:

    Consulting role, 1099 / freelance

  • Location:

    remote working, global opportunity

  • Duration:

    6-12 month, ad-hoc hours

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