Regulatory Ad Promo Associate Director

Neurocrine Biosciences · San Diego, CA

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RegulatoryFull-time$174k–$238kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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