Description

You will provide regulatory advice and coordinate activities to obtain and maintain approvals for investigational products. You'll manage submissions of regulatory documents to global health authorities and collaborate with cross-functional teams to ensure compliance and support business strategy.

Requirements

• Bachelor's degree in relevant field
• 5-7 years direct regulatory experience
• Strong knowledge of US FDA pharmaceutical regulations
• Proven track record of successful submissions
• Strong team player with excellent communication skills

Responsibilities

• Manage planning, preparation, and submission of regulatory documents to global health authorities
• Correspond and collaborate with colleagues across departments
• Function as Regulatory Affairs subject matter expert on cross-functional teams
• Perform regulatory research to inform business strategy
• Develop regulatory strategies to inform budgets and tools