Senior Manager, Regulatory Affairs

Job Summary

A company is looking for a Senior Manager, Regulatory Affairs Advertising and Promotion.

Key Responsibilities

• Provide strategic regulatory advice on communications regarding investigational and approved products
• Review and assess promotional materials to ensure compliance with FDA regulations and company policies
• Monitor changes in the regulatory environment and train personnel on relevant regulations

Required Qualifications

• Bachelor's degree in science or a health-related discipline; advanced degree preferred
• 6+ years of relevant pharmaceutical industry experience
• 4+ years of experience in prescription product advertising and promotion review
• Broad knowledge of regulatory affairs for prescription drugs
• Experience with Form 2253 submissions and Veeva PromoMats is a plus