Regulatory Ad Promo Associate Director

Neurocrine Biosciences seeks a Regulatory Ad Promo Associate Director to lead review of medical education and promotional materials for FDA compliance. The role involves cross-functional collaboration, regulatory guidance assessment, and process improvement for advertising and promotion functions.

Responsibilities

• Lead review of medical education, commercial advertising, and promotional materials for FDA compliance and regulatory guidance adherence
• Conduct timely regulatory review and submission of promotional materials including FDA 2253 submissions
• Represent Regulatory Affairs independently on Medical Review Committee and ensure promotional claims comply with approved labeling and regulations
• Track FDA guidance and policies; communicate potential regulatory risks and impacts to senior leadership
• Mentor junior team members and identify process improvements to enhance efficiencies and compliance

Requirements

• Bachelor's degree in Life/Health Sciences plus 10+ years regulatory affairs experience, or Master's degree plus 8+ years similar experience
• Significant experience managing advertising and promotion processes in biotech, pharmaceutical, or device companies
• Proven track record with FDA advertising and promotional review committees and regulatory guidelines
• Advanced proficiency with electronic document management systems such as Veeva Vault
• Strong communication, analytical thinking, problem-solving, and influencing skills
• Ability to work independently with minimal direction and represent regulatory affairs on committees
• Advanced skills in Microsoft Office and Adobe Professional