SR Coordinator, Regulatory Submission Operations

SR Coordinator, Regulatory Submission Operations

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for an SR Coordinator, Regulatory Submission Operations based in the United States.

In this role, you will support regulatory submission operations by preparing, formatting, editing, and compiling essential documentation for pharmaceutical product registrations and regulatory approvals. You will play a key part in ensuring that submission materials meet quality standards, follow established procedures, and are delivered within agreed timelines. Working in a remote environment, you will collaborate with clients and internal stakeholders to coordinate documents and maintain accurate submission records.

You will use specialized publishing software and document management systems to process regulatory materials throughout the pharmaceutical product lifecycle. Your attention to detail and ability to manage complex documentation will help maintain the accuracy, consistency, and integrity of regulatory submissions. This opportunity is ideal for a detail-oriented professional who enjoys problem-solving, working independently, and coordinating multiple priorities. You will contribute to regulatory processes that support pharmaceutical compliance and help bring healthcare products to market efficiently.

• Coordinate regulatory submission activities, including preparing, formatting, editing, and compiling paper-based and electronic documents for pharmaceutical regulatory applications.
• Assess project requirements, establish realistic timelines, and negotiate deadlines with relevant stakeholders to support timely and efficient submission delivery.
• Manage client-provided documentation, ensuring that files are complete, accurate, organized, and ready for regulatory processing.
• Process and format client documents using specialized regulatory publishing software, ensuring compliance with applicable submission specifications and quality standards.
• Prepare specialized electronic files to support drug registrations, product listings, licensing applications, renewals, and other regulatory submission activities, as required.
• Maintain document management databases and ensure effective version control, revision tracking, and document integrity throughout the submission process.
• Perform quality assurance and quality control checks to identify formatting inconsistencies, documentation errors, and potential compliance concerns before submission.
• Identify issues, communicate effectively with upstream and downstream partners, and coordinate appropriate resolutions to minimize delays and maintain submission quality.
• Apply established procedures and technical expertise to resolve complex documentation challenges independently, adapting processes when appropriate and within authorized guidelines.
• Provide general guidance and technical assistance to less experienced team members when needed, while contributing to continuous improvement in submission operations.

• Demonstrated experience with advanced Microsoft Word document formatting is required, including the ability to manage complex document structures and maintain consistent formatting.
• Experience formatting and editing Adobe documents is required, with the ability to prepare professional, accurate, and submission-ready electronic files.
• Familiarity with Microsoft Excel is required for managing information, reviewing data, and supporting documentation workflows.
• Experience with quality assurance (QA), quality control (QC), and standard operating procedures (SOPs) is a strong advantage.
• Editorial experience, data analysis skills, and project management experience are preferred.
• Ab…