Director, Regulatory Affairs Advertising & Promotion - Remote

Overview

The Director Regulatory Affairs, US Advertising and Promotion is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan.

In Short

• Advise cross-functional teams on content and message consistency.
• Ensure compliance with approved company processes for advertising and promotion.
• Train regulatory staff as required.
• Provide regulatory guidance for advertising materials and campaigns.
• Review and approve advertising and promotion materials.
• Lead cross-functional review team meetings.
• Apply DDMAC guidance to business situations.
• Make challenging regulatory decisions and elevate as necessary.
• Advise on FDA 2253 submissions.
• Collaborate with RA labeling group on package insert changes.

Requirements

• Bachelor's Degree in science (biology, chemistry, etc.).
• Master’s, Ph.D. or Pharm D preferred.
• 10 years of pharmaceutical experience.
• 5 years of direct advertising and promotion review experience.
• Strong understanding of regulatory advertising and promotion regulations.

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• Paid time off (vacation, holidays, sick leave).
• Participation in short-term and long-term incentive programs.