Manager, Regulatory Affairs Submission Management - Hybrid

Role: Regulatory Affairs Submission Management Manager overseeing high-impact regulatory submission projects, ensuring timely delivery of high-quality dossiers aligned with agency standards. Responsibilities include managing cross-functional teams, establishing submission timelines and content plans, coordinating publishing with offsite vendors, and ensuring compliance through detailed quality reviews. Acts as primary interface with project teams, providing guidance on submission processes and standards, and develops process improvements. Qualifications: Bachelor’s degree; 6+ years in pharmaceutical industry with experience in publishing software tools (e.g., Documentum, Adobe Acrobat) and project management; PMP and RAC certifications are advantageous. Preferred: Regulatory Affairs experience; leadership skills; background in regulatory submission publishing or related fields such as QA or R&D. High-Value: Complex submission projects supporting development, marketing, or post-marketing activities; expertise in regulatory standards, GxP compliance, and cross-functional collaboration. Work setup and travel details are not specified.