Senior Associate Regulatory Affairs Submission Management - Hybrid

📋 Description

• Manage medium to high impact regulatory submission projects with cross-functional teams
• Establish and maintain submission content planners and timelines
• Facilitate submission team meetings and coordinate publishing timelines
• Interface with publishing vendor and resolve publishing issues
• Provide technical systems support and SME guidance in RA submissions
• Lead process improvements and mentor staff where applicable

🎯 Requirements

• Bachelor’s degree required; years of experience may offset education
• Four years’ pharma/industry experience with publishing tools (Documentum, eCTDXPress/ISIPublisher
• Preferred: PMP and RAC certificates
• Regulatory Affairs experience beneficial; regulatory operations/submission publishing preferred
• Proven leadership and ability to influence without direct authority

🎁 Benefits

• Comprehensive benefits package including PTO and health insurance
• 401(k) plan eligible for employees
• Short-term incentive programs where applicable