• Manage regulatory strategy and material approvals for labeling, advertising, and promotion
• Ensure compliance and provide strategic regulatory guidance
• Collaborate with cross-functional teams
• Oversee staff and coordinate regulatory document assembly
• Organize team meetings on management of change controls and labeling supplements

Requirements

Bachelor's degree in science with 10+ years of broad professional experience in Regulatory Affairs
Regulatory affairs certified (RAC) preferred
Demonstrated experience leading and managing regulatory submissions
Experience in reviewing and approving advertising and promotional materials within a pharmaceutical organization
Good interpersonal skills and strategic business perspective
Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly in North America

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Hard Skills

regulatory strategy
regulatory submissions
labeling approvals
advertising approvals
promotion approvals
document assembly
change controls
labeling supplements

Soft Skills

interpersonal skills
strategic business perspective
leadership
collaboration

Certifications & Qualifications

Regulatory Affairs Certified (RAC)

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