Regulatory Strategy Consultant – Oncology REF:1123
Global development and FDA experience are absolutely essential. In addition to the above an awareness/anticipation of any changes in the global setting outside the US is also highly important.
The ideal candidate will:
- Have a strong understanding of the FDA and EMA regulations and precedents for both regulatory and competitors in development. Can articulate potential challenges/additional requirements for a global development, with particular focus on PMDA/CDE requirements.
- Guide the cross-functional team in joint planning meetings which occur every 2 weeks
- Develop the global regulatory strategy throughout development and to submission
- Guide the Team in preparations for internal governance and agency meetings planned for 1H 2022.
The project is to develop the overall regulatory strategy for an oncology fixed-dose combination product of 3 novel drugs which are currently all intravenously administered sequentially. Based on current timelines, data to support the switch will become available during phase III registration trials. This is very complex with a strong regulatory, clinical and CMC component. The consultant must have strong FDA experience, EMA and PMDA.
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