Senior Regulatory Affairs Specialist - Ad / Promo
EPM ScientificLenoir, NC, United Statesjob_description.job_card.variable_days_ago
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- serp_jobs.job_card.full_time
job_description.job_card.job_description3-5 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
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 :
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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Regulatory Specialist • Lenoir, NC, United States