Associate Director, Global Submission Management

Associate Director, Global Submission Management

The Associate Director of Global Submission Management (GSM) is responsible for leading, managing, strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This role involves providing hands-on operational support for submission activities while ensuring strategic alignment and process optimization across different regions. It also includes resource planning, budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads of Submissions Management for the EU and Japan as needed and utilize “Follow-the-sun” processes to ensure submission timelines are met regardless of the region.

The Associate Director, Global Submission Management (GSM, is responsible for the effective operation of Global Submission projects, ensuring the consistent application of global procedures and standards, and proactively assessing process performance for necessary optimizations. The Associate Director serves as the primary liaison between R&D functions, acting as the submission lead for designated global applications (e.g., INDs, NDAs, MAAs, supplements, amendments, and variations), to facilitate cross-functional logistics and communication that support submission planning. This role provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in accordance with agreed-upon submission timelines. Additionally, the AD oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final deliverables, ensuring compliance with applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, HC, PMDA, Emerging Markets, ICH, CDISC) within defined timelines.

Essential Functions:

Leadership and Strategy

• Provides leadership for the Global Submissions Team ensuring projects are appropriately resourced, partnering with other regional Submission Heads for additional support for resources when needed.
• Provides the Regulatory Submission Management for a lead compound or submission project that has been identified as critical to business success.
• Provides management oversight for the Global Submission Management department, supporting the generation, and when necessary, the re-engineering of “Best Practices” related to global submission management and dossier development in pursuit of optimal processing performance while maintaining full compliance with Health Authority requirements and guideline.

Global Collaboration

• Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement “follow-the-sun” workflows for timely submissions across all regions.
• Foster strong cross-regional communication and collaboration to support global objectives.
• Promotes a culture of performance and teamwork, with a focus on staff development in technical skills, interpersonal skills, education, and training, enhancing competency and professionalism.
• Maintains visibility within the organization by regularly presenting on various GSM-related topics. This includes showcasing the achievements, ongoing projects, and developments of the GSM organization, as well as emerging trends in eCTD regulatory submissions. Additionally, cultivate positive and constructive relationships with other members of the Global Regulatory Operations (GRO) team and regulatory colleagues.
• Actively participates in agency/industry events regularly, staying abreast of current developments, trends, and technologies, fostering constructive business relations with other industry peers, Health Authority representatives, and critical business partners/vendors.
• Analyzes trends and evaluates the impact of changes in Health Authority requirements for e-submissions, communicating these changes to the relevant areas within and driving the necessary changes to processes and procedures.
• Ensure the timely completion of all administrative tasks for this position, including but not limited to monthly reports, performance objective setting, performance reviews, and training, for self and staff.

Hands-On Submission Support

• Actively participates in submission planning and execution, including document compilation, publishing, and quality checks.
• Provide technical oversight and troubleshooting for eCTD submissions and related systems.

Operational Excellence

• Ensure consistent application of GSM global procedures and standards.
• Proactively monitors and assess process performance, identifying opportunities for continuous improvement.

Requirements

• Bachelor’s degree in scientific or information technology field; advanced degree preferred
• 8+ years of pharmaceutical industry regulatory experience
• 5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required
• Proficient with U.S. and EU submission requirements including but not limited to Emerging Markets
• Advance experience with the drug development process and eCTD regulatory submission standards
• Expert understanding of Project Management concepts and techniques
• Ability to apply SOPs regulations pertaining to electronic submissions
• Ability to lead cross-functional team, establish effective relationships with team members and work well in a cross functional team environment
• Advance experience creating timelines for the development and submission of drug filings to regulatory health authorities
• Excellent organizational skills to support multi-task and manage submission timelines in a fast-paced environment with changing priorities
• Well-organized with the ability to multi-task and work with minimal supervision
• Ability to manage change to support organization’s effectiveness by implementing change
• Effectively communicates written and verbal communication skills
• Demonstrates strong analytical, problem solving and critical thinking skills with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.
• Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)

Technical Skills Required

• Advance working knowledge of global regulatory submission standards, publishing software, software validation concepts, and regulatory publishing best practices
• Proficiency in eCTD publishing tools (e.g., Lorenz docuBridge, Extedo eCTDmanager, or equivalent).
• Strong understanding of ICH guidelines , regional regulatory requirements , and data standards (e.g., CDISC).
• Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (e.g., Veeva Vault, SharePoint, Documentum)
• PowerPoint, SharePoint, XML, Adobe Acrobat, ISI Toolbox and eData transfer systems
• Ability to troubleshoot technical issues related to electronic submissions and publishing.