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.

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