Manager, Regulatory Submission

Role Overview

• Manage submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities
• Participate in submission team meetings
• Coordinate multiple concurrent interrelated activities for submission projects for products in the delivery of published submissions within required timelines
• Anticipate obstacles and develop solutions within the team
• Coordinate submission publishing with publishers and provides notification to ensure all required resources are available to meet submission timelines
• Prepare content planner for publishing and work with team members to resolve publishing issues
• May perform publishing tasks
• Assist with team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidances

Requirements

• Bachelor’s degree
• Minimum 8 years of relevant experience in the biotech or pharmaceutical industry
• Minimum 2 years of experience working with submission content planning
• Strong working knowledge of regulatory submission publishing standards and procedures including word processing and regulatory publishing software
• Preferred: Experience working with Veeva RIM document management system
• Experience working with LORENZ docuBridge FIVE
• Experience working with Accenture StartingPoint
• Utilizing Smartsheet for submission content planning
• Experience producing eCTD U.S. and MAA submission

Benefits

• Discretionary annual target bonus
• Stock options
• ESPP
• 401k match
• Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
• 20 days of PTO
• 10 paid holidays
• Winter company shutdown