Take a pivotal role in regulatory affairs with Lundbeck as a Manager in Deerfield, IL. Lead regulatory publishing and submissions, ensuring compliance and quality throughout the product lifecycle.
This position provides technical and operational leadership in Regulatory Affairs Operations. With over five years of experience in the pharmaceutical industry, you will oversee IND, NDA, BLA, and DMF submissions in eCTD format. Your expertise will drive process optimization and capability development while supporting cross-functional teams and vendors.
Key Responsibilities:
• Provide oversight and quality accountability for regulatory submissions
• Manage critical publishing components for submission readiness
• Serve as an escalation point for complex publishing issues
• Support modernization initiatives for publishing processes
• Deliver training on publishing standards across departments
Requirements:
• Accredited bachelor's degree required
• 5+ years in Regu...