Clark Davis Associates
Associate Director Regulatory Affairs (Global Submission)
Clark Davis Associates, Trenton, New Jersey, United States
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 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.
Job requirements
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
Skills needed
Hands-on experience with eCTD publishing platforms such as Lorenz docuBridge, 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
#J-18808-Ljbffr
Responsibilities 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.
Job requirements
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
Skills needed
Hands-on experience with eCTD publishing platforms such as Lorenz docuBridge, 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
#J-18808-Ljbffr