Description

You will lead regulatory strategies and manage submissions for novel oncology therapies targeting RAS-addicted cancers. Collaborate cross-functionally to obtain and maintain global health authority approvals, ensuring compliance and informing business decisions.

Requirements

• Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience
• Strong working knowledge of US FDA Pharmaceutical regulations and guidance
• Proven track record of successful submissions within a regulatory environment
• Exceptionally strong team player with excellent interpersonal and communication skills
• Detail-oriented with strong organizational skills and high-quality standards

Responsibilities

• Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities
• Correspond and collaborate with RevMed colleagues and departments to achieve alignment
• Function as a Regulatory Affairs subject matter expert on cross-functional teams
• Perform regulatory research to inform business strategy and assess risks
• Develop regulatory strategies to inform budgets, tools, and specialized support