Description

You will partner with cross-functional teams to ensure promotional and medical communication strategies comply with regulations and industry standards, supporting successful product commercialization while upholding regulatory integrity and scientific accuracy.

Requirements

• Bachelor's degree in a relevant field and 10 years of relevant experience
• 5-7 years of promotional regulatory affairs experience in biotech/pharma for US market
• Strong understanding of FDA regulations governing promotional activities
• Understanding of scientific exchange and pre-approval discussions
• Excellent communication skills and collaborative mindset

Responsibilities

• Serve as primary/secondary regulatory advertising and promotion reviewer on MLR teams
• Manage regulatory submissions of promotional materials (e.g., FDA Form 2253)
• Interpret evolving regulatory requirements to guide commercial strategy and risk assessments
• Train cross-functional teams on commercial regulatory compliance and MLR best practices
• Monitor US regulatory promotional environment via guidelines, warning letters, and industry meetings