SR Coordinator, Regulatory Submission Operations

📋 Description

• Coordinate regulatory submission activities, including preparing, formatting, editing, and
• Assess project requirements, establish realistic timelines, and negotiate deadlines with relevant
• Manage client-provided documentation, ensuring that files are complete, accurate, organized, and
• Process and format client documents using specialized regulatory publishing software, ensuring
• Prepare specialized electronic files to support drug registrations, product listings, licensing
• Maintain document management databases and ensure effective version control, revision tracking, and

🎯 Requirements

• Demonstrated experience with advanced Microsoft Word document formatting is required, including the
• Experience formatting and editing Adobe documents is required, with the ability to prepare
• Familiarity with Microsoft Excel is required for managing information, reviewing data, and
• Experience with quality assurance (QA), quality control (QC), and standard operating procedures
• Editorial experience, data analysis skills, and project management experience are preferred.
• Ability and willingness to learn scientific and pharmaceutical regulatory principles, terminology

🎁 Benefits

• Hourly compensation: Anticipated pay range of $27.00–$34.56 per hour, depending on factors such as
• Remote work: Opportunity to work remotely within the United States.
• Healthcare coverage: Medical, dental, and vision insurance plans.
• Retirement savings: Access to a 401(k) savings plan.
• Paid time off: Paid time off benefits to support personal needs and work-life balance.
• Health savings account (HSA): Access to an HSA to help manage eligible healthcare expenses.