Description

You will lead regulatory submissions and strategy for oncology drug development, collaborating with cross-functional teams to obtain and maintain approvals from global health authorities, with a focus on FDA regulations.

Requirements

• Bachelor's degree in relevant field
• 5+ years direct Regulatory experience
• Strong knowledge of US FDA regulations
• Proven track record of successful submissions
• Team player with strong communication skills

Responsibilities

• Manage planning and submission of regulatory documents to global health authorities
• Collaborate with cross-functional teams to achieve alignment
• Function as Regulatory subject matter expert on study and submission teams
• Perform regulatory research to inform business strategy
• Develop regulatory strategies for budgets and operational support