Meet our People | Joshua Lett, Regulatory Operations Specialist II

This video provides an overview of the critical role of a Regulatory Operations Specialist within the pharmaceutical and life sciences ecosystem, focusing specifically on the methodologies and proprietary tools used by Certara Synchrogenix to manage complex regulatory submissions. The speaker, Joshua Lett, highlights that the firm's unique value proposition stems not only from the deep experience of its internal regulatory operations (Reg Ops) team but also from the utilization of their specialized internal publishing software, "Global Submit." This software is positioned as a key technological asset that enables a proactive and highly efficient approach to electronic Common Technical Document (eCTD) publishing and submission management.

The core of the presentation details two distinct, yet interconnected, features within the Global Submit software designed to enhance submission quality and regulatory success. The first is the Validation Feature. This tool is described as being truly unique because it allows the Reg Ops team to take a proactive stance in identifying and eliminating potential validation errors long before the official submission date. By catching these errors early, the team ensures that when the submission is ready, it is secure and successful upon transmission through the Electronic Submission Gateway (ESG) to the specified governing health agency. This proactive error mitigation is crucial for maintaining compliance and avoiding costly delays associated with submission rejections.

Working in tandem with the validation capabilities is the Lifecycle Feature. This functionality provides a retrospective view of all previously submitted sequences within a given regulatory application. The speaker emphasizes that this feature allows specialists to review all historical documents, relevant metadata, and sequence properties. This historical data is then leveraged strategically to prepare adequately for the current submission at hand. Furthermore, the ability to analyze past submission patterns and data enables the team to proactively plan and prepare for future submissions, transforming the regulatory process from a reactive task into a strategically managed, forward-looking operation. The combination of proactive validation and retrospective lifecycle analysis ensures comprehensive control over the entire regulatory submission process.

Key Takeaways: • Strategic Importance of Proactive Validation: The video underscores that relying on proprietary software with advanced validation features allows regulatory operations teams to shift from reactive error correction to proactive identification and elimination of potential validation errors, significantly reducing the risk of submission failure. • Ensuring Secure Transmission via ESG: A primary goal of the validation process is to guarantee a secure and successful transmission of the eCTD through the Electronic Submission Gateway (ESG) to the governing health agency, highlighting the necessity of robust technical checks prior to final delivery. • Leveraging Submission Lifecycle Data: The Lifecycle Feature provides immense strategic value by offering a retrospective look at all historical sequences, documents, and metadata associated with an application, which is essential for maintaining consistency and compliance across subsequent submissions. • Data-Driven Preparation for Future Submissions: Access to comprehensive lifecycle data allows regulatory teams to use historical sequence properties and metadata to adequately prepare not only for the immediate submission but also to proactively plan for regulatory submissions that are scheduled further in the future. • Technology as a Competitive Advantage: The use of internal, specialized publishing software (Global Submit) is presented as a crucial differentiator, demonstrating how technological investment in regulatory tools enhances the efficiency and expertise offered to life sciences clients. • Integration of Expertise and Technology: Successful regulatory operations require the combination of deep human expertise (the internal Reg Ops team) and advanced technological tools (Global Submit) to navigate the complexities of eCTD publishing and regulatory requirements. • Metadata Management is Critical: The emphasis on reviewing "relevant metadata" within the lifecycle feature suggests that effective management and tracking of submission metadata are as critical as the document content itself for successful regulatory filing and long-term application management. • Regulatory Operations as a Strategic Function: The approach described moves regulatory operations beyond simple document compilation into a strategic function focused on risk mitigation, data analysis, and long-term planning for the entire drug development lifecycle.

Tools/Resources Mentioned:

• Global Submit: Certara Synchrogenix’s proprietary internal publishing software used for eCTD preparation and submission management.
• Electronic Submission Gateway (ESG): The secure transmission channel used to deliver regulatory submissions to governing health agencies.

Key Concepts:

• Regulatory Operations (Reg Ops): The specialized function within life sciences companies responsible for the preparation, publishing, and submission of regulatory documents (like eCTD) to health authorities (e.g., FDA, EMA).
• Validation Feature: A software function that automatically checks regulatory submissions against technical specifications and requirements to identify and flag errors that could lead to rejection or delay.
• Lifecycle Feature: A software function that provides a historical record and analysis of all previously submitted sequences, documents, and associated metadata within a single regulatory application.
• eCTD (Electronic Common Technical Document): The standard format for submitting regulatory applications, amendments, and updates to health authorities worldwide.