Senior Regulatory Affairs Specialist - Ad/Promo

Overview:

A growing biopharmaceutical company is seeking a Senior Regulatory Affairs Specialist with a focus on advertising and promotional review. This role leads the end-to-end review process for promotional and non-promotional content across a diverse product portfolio, while also supporting regulatory submissions and updates across North America.

Key Responsibilities:

• Manage review and approval of promotional, advertising, and training materials
• Ensure compliance with FDA, CBER, OPDP, and other regulatory bodies
• Oversee workflows in Veeva PromoMats, including metadata validation and reviewer coordination
• Facilitate live MLR meetings and track feedback/action items
• Support regulatory submissions and license renewals for U.S., Canada, and USDA
• Continuously improve SOPs and review processes for efficiency and compliance
• Mentor cross-functional teams on regulatory best practices
• Monitor regulatory changes and communicate updates internally

Qualifications:

• 3-5 years of regulatory affairs experience in biopharma or medical devices
• 1+ year of experience in advertising/promotional review
• Strong knowledge of FDA, CBER, OPDP regulations
• Experience with Veeva PromoMats and regulatory submissions
• Excellent communication, project management, and collaboration skills
• Bachelor's degree in a scientific discipline preferred
• RAC certification strongly preferred

Why Apply?

This is a high-impact role within a mission-driven organization, offering the opportunity to shape promotional strategy and ensure regulatory excellence across a growing portfolio.