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| About our client |
| Our client is committed to developing, acquiring, and commercializing innovative treatments for cancer. The company pursues making cancer more treatable. They are developing a diversified portfolio of oncology products focused on identifying new, less toxic and more effective cancer therapies. |
| Position |
Location |
| Director of Regulatory Affairs |
Washington |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Oversee company development and post-marketing projects 2) Lead global strategy development and all regulatory affairs activities and submissions 3) Interface across company functional groups, health authorities and contract service providers |
| Requirements |
1) Bachelor’s degree 2) 12+ years of regulatory experience in pharmaceutical and/or biopharmaceutical product development and commercialization 3) Oncology experience preferred 4) Experience in negotiating with regulatory agencies 5) Familiarity with preparing clinical trial applications and registration dossiers 6) Foreign regulatory experience a plus 7) Ability to meet and prepare INDs and NDAs 8) Ability to interact with the FDA |

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