Description

You will provide regulatory advice, manage submissions to global health authorities, and collaborate across teams to advance novel oncology therapies for RAS-addicted cancers.

Requirements

• Bachelor's degree in relevant field
• 5-7 years of direct regulatory experience
• Strong knowledge of US FDA pharmaceutical regulations and guidance
• Proven track record of successful regulatory submissions
• Detail-oriented with strong organizational and communication skills

Responsibilities

• Manage planning, preparation, and submission of regulatory documents to global health authorities
• Correspond and collaborate with cross-functional teams to achieve alignment
• Function as regulatory subject matter expert on study and submission teams
• Assess and communicate regulatory risks to inform business strategy
• Develop regulatory strategies to inform budgets and specialized support