AD, Global Submission Mgmt

Date Posted: 12/9/2025

Associate Director, Global Submission Management
Location: Northern NJ (Hybrid: Onsite 3 days/week if local; Remote for East Coast candidates)

A leading global biotech company in Northern New Jersey is seeking an Associate Director, Global Submission Management (GSM) to lead the planning, execution, and delivery of complex global regulatory submissions. This role provides both strategic oversight and hands-on operational leadership to ensure high-quality, timely submissions across all regions in alignment with global regulatory standards.

The Associate Director will collaborate closely with regional Submission Management leads in the U.S., EU, and Japan, maximizing efficiencies through “follow-the-sun” workflows. This position also plays a key role in resource planning, process optimization, vendor oversight, and cross-functional coordination to support Global Regulatory Operations (GRO) objectives.

Key Responsibilities:
Leadership & Strategic Oversight: Lead and manage the Global Submissions team, ensuring appropriate resourcing and partnering with regional submission heads as needed. Serve as the Regulatory Submission Lead for major global programs and critical regulatory filings (e.g., INDs, NDAs, MAAs, supplements, variations). Oversee and continuously refine best practices for global submission management and dossier development to enhance efficiency while maintaining full compliance with Health Authority guidelines. Drive creation, maintenance, and execution of the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory deliverables.

Global Collaboration: Partner with EU and Japan Heads of Submission Management to implement coordinated, cross-regional workflows that support timely, around-the-clock submissions. Champion strong communication and collaboration across global teams to support strategic submission planning and operational alignment. Promote a high-performance, growth-focused team culture through ongoing development in technical, interpersonal, and leadership skills. Maintain organizational visibility by presenting GSM updates, achievements, and emerging regulatory trends, including advancements in eCTD. Represent the organization n at agency/industry events to stay current with evolving regulations, technologies, and best practices. Assess and communicate the impact of Health Authority requirement changes, driving updates to processes and procedures when necessary. Ensure timely completion of administrative responsibilities, including reporting, performance management, and training.

Hands-On Submission Execution: Actively support submission planning, document compilation, publishing, and quality review activities. Provide technical oversight and troubleshooting for eCTD submissions, publishing tools, and related systems.

Operational Excellence: Ensure consistent execution of global GSM procedures and standards. Monitor and evaluate submission processes to identify opportunities for continuous improvement.

Qualifications:
Bachelor’s degree in a scientific or IT field; advanced degree preferred. 7+ years of regulatory experience in the pharmaceutical or biotech industry. 4+ years of experience in submissions management, process development, and major electronic submissions. Strong knowledge of U.S., EU, and Emerging Market regulatory submission requirements. Advanced understanding of the drug development process and eCTD standards. Expertise in project management principles, including timeline development for regulatory filings. Ability to lead cross-functional teams, build strong partnerships, and manage priorities in a fast-paced environment. Excellent written and verbal communication, organizational, analytical, and problem-solving skills. Familiarity with regulations and SOPs governing electronic submissions. RAPS or similar professional certification is a plus.

Technical Skills:
Advanced proficiency in global submission standards, publishing software, system validation concepts, and regulatory publishing best practices. Experience with eCTD publishing tools (e.g., Lorenz docuBridge, Extedo eCTDmanager). Strong understanding of ICH guidelines, regional regulatory requirements, and data standards (e.g., CDISC). Extensive experience with RIM and Document Management Systems (e.g., Veeva Vault, Documentum, SharePoint). Proficiency with PowerPoint, SharePoint, XML, Adobe Acrobat, ISI Toolbox, and eData transfer systems. Ability to troubleshoot technical issues related to electronic submissions and publishing workflows.

Please contact Darren Gutowski at dgutowski@clarkdavis.com