Manager, Regulatory Affairs Submission Management - Hybrid

📋 Description

• Lead complex RA submission projects with cross-functional teams.
• Maintain submission content planners and timelines.
• Interface with publishing vendors and internal teams.
• Provide guidance on submission processes and specs.
• Coordinate publishing and ensure regulatory compliance.
• Mentor staff and drive process improvements.

🎯 Requirements

• Bachelor’s degree required.
• 6 years pharma or related experience with publishing tools.
• Experience with Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight, Adobe Acrobat.
• Regulatory Affairs experience preferred; QA/R&D/support acceptable.
• Proven leadership and project management skills.

🎁 Benefits

• Competitive compensation package.
• Medical/dental/vision insurance.
• 401(k) plan and long-term incentives.