Associate Director Regulatory Affairs; Global Submission

Overview

The Associate Director Regulatory Affairs (Global Submission), leads the end-to-end execution of global regulatory submissions, ensuring timely, high-quality delivery in compliance with global regulatory requirements. This role provides both strategic oversight and hands-on operational leadership for major submissions, driving consistency, efficiency, and cross-regional alignment.

Responsibilities include serving as submission lead for global applications (e.g., INDs, NDAs, MAAs, amendments, and variations), coordinating cross-functional stakeholders, managing resources and vendors, and maintaining the Global Submission Content Plan. The role partners closely with regional submission leads (EU and Asia) and leverages follow-the-sun processes to meet aggressive timelines while ensuring adherence to FDA, EMA, PMDA, ICH, CDISC, and emerging market standards.

• Bachelor’s degree in scientific or information technology field; advanced degree preferred
• 7-10+ years of pharmaceutical industry regulatory experience
• 5-8+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required
• Strong knowledge of U.S. and EU regulatory submission requirements, including Emerging Markets
• Advanced experience across the drug development lifecycle and eCTD submission standards
• Proven ability to develop and manage regulatory submission timelines for global health authority filings
• Highly organized with the ability to manage multiple submissions in a fast-paced, deadline-driven environment
• Demonstrated capability to work independently with minimal supervision while maintaining accuracy and accountability
• Adaptable to change, with experience implementing process improvements to support organizational effectiveness
• Clear and effective written and verbal communication skills

• Hands-on experience with eCTD publishing platforms such as Lorenz docu Bridge, Extedo eCTDmanager, or comparable tools
• In-depth knowledge of ICH guidelines, global regulatory requirements, and industry data standards, including CDISC
• Extensive experience working with Regulatory Information Management (RIM) systems and document management platforms such as Veeva Vault, SharePoint, and Documentum