CMC Regulatory Consultant - Hamilton

Only for registered members Hamilton, Canada

2 weeks ago

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Job summary

We are hiring a CMC Regulatory Consultant for one of our radiopharmaceutical clients based in Hamilton, Ontario. The CMC Regulatory Consultant will support global regulatory interactions by leading the coordination, review and regulatory alignment of Health Authority Questions (HAQs) related to CMC.

Responsibilities

  • Serve as the CMC regulatory point of contact for global Health Authority Questions (e.g. FDA, EMA, MHRA, PDMA, other regions as applicable).
  • Train on the company's ERV/Veeva Vault system and manage HAQ responses within the ERV system.

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