Senior Manager Regulatory Affairs Advertising & Promotion

Role: Senior Manager Regulatory Affairs Advertising & Promotion, specializing in managing regulatory review processes for promotional materials within a biopharma setting. Responsibilities: coordinate PRC activities, facilitate and document review comments, maintain Veeva Vault libraries, manage FDA Form 2253 submissions including scheduling, review content, verify successful submission, update label change communications, and oversee audit preparations. Provide strategic support on 2253 submissions, ensure compliance with submission guidelines, review materials, and implement process improvements. Qualifications: Bachelor's degree or equivalent with 5+ years of regulatory experience, strong knowledge of regulatory operations, experience with Veeva Vault, and proficiency in regulatory document submission. Skills: excellent communication, collaboration, adaptability, and ability to manage multiple priorities in a fast-paced environment. High-Value: focus on advertising and promotional material review, FDA submissions, label updates, and compliance monitoring within a biopharma context. Travel: up to 15%.