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Regulatory Affairs Senior Director

Our global leading biotechnology company specializes in the research, clinical development, and commercialization of cancer immunotherapy treatments. They have a robust pipeline of both pre-clinical and clinical treatments, targeting multiple cancer indications. They have a Phase III trial registered with the FDA and they expect filing 2020-2021. The commercialization plan is to launch globally (Asia and US simultaneously). The US launches early on will be ultra- orphan.

They currently have 130 employees from 25 different countries and are a very global international company inclusive of Asia, US and Europe. They are building out their US presence and aspire to hire the Head of Regulatory Affairs to be based remotely in the US and manage a global team of (4) four.

The Head of Regulatory Affairs must have solid FDA and oncology experience and be able to develop and implement regulatory strategies aimed at achieving marketing approvals and appropriate product labeling in the US. This person will be responsible for directing all regulatory activities from pre-clinical development through filing of marketing applications and post-approval activities in the US.

The Head of Regulatory will report into the COO.

This is an opportunity to build not just structure within the regulatory department but to build out capabilities and influence how the regulatory team will function. This is for the entrepreneurial spirited individual wanting to make an impact.

If you would like to be part of a team that is focused on curing cancer and saving lives, contact Jackie Bandish at 267-483-5233 x 104 or jackie@bandishgroup.com.



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