SR Coordinator, Regulatory Submission Operations

<h3>Accountabilities:</h3><li>Coordinate regulatory submission activities, including preparing, formatting, editing, and compiling paper-based and electronic documents for pharmaceutical regulatory applications.</li><li>Assess project requirements, establish realistic timelines, and negotiate deadlines with relevant stakeholders to support timely and efficient submission delivery.</li><li>Manage client-provided documentation, ensuring that files are complete, accurate, organized, and ready for regulatory processing.</li><li>Process and format client documents using specialized regulatory publishing software, ensuring compliance with applicable submission specifications and quality standards.</li><li>Prepare specialized electronic files to support drug registrations, product listings, licensing applications, renewals, and other regulatory submission activities, as required.</li><li>Maintain document management databases and ensure effective version control, revision tracking, and document integrity throughout the submission process.</li><li>Perform quality assurance and quality control checks to identify formatting inconsistencies, documentation errors, and potential compliance concerns before submission.</li><li>Identify issues, communicate effectively with upstream and downstream partners, and coordinate appropriate resolutions to minimize delays and maintain submission quality.</li><li>Apply established procedures and technical expertise to resolve complex documentation challenges independently, adapting processes when appropriate and within authorized guidelines.</li><li>Provide general guidance and technical assistance to less experienced team members when needed, while contributing to continuous improvement in submission operations.</li><h2>Requirements:</h2><li>Demonstrated experience with advanced Microsoft Word document formatting is required, including the ability to manage complex document structures and maintain consistent formatting.</li><li>Experience formatting and editing Adobe documents is required, with the ability to prepare professional, accurate, and submission-ready electronic files.</li><li>Familiarity with Microsoft Excel is required for managing information, reviewing data, and supporting documentation workflows.</li><li>Experience with quality assurance (QA), quality control (QC), and standard operating procedures (SOPs) is a strong advantage.</li><li>Editorial experience, data analysis skills, and project management experience are preferred.</li><li>Ability and willingness to learn scientific and pharmaceutical regulatory principles, terminology, and submission requirements.</li><li>Exceptional attention to detail, with a strong commitment to accuracy, consistency, document integrity, and quality standards.</li><li>Strong written and verbal communication skills, with the ability to coordinate effectively with clients, internal teams, and other stakeholders.</li><li>Strong organizational and time management skills, including the ability to assess competing priorities, manage multiple deadlines, and negotiate timelines effectively.</li><li>Proven problem-solving abilities and the capacity to work independently within established procedures, exercise sound judgment, and resolve complex issues with minimal supervision.</li><li>Ability to adapt to changing requirements, follow established policies, and provide technical support or guidance to colleagues when necessary.</li><h2>Benefits:</h2><li>
<strong>Hourly compensation:</strong>Anticipated pay range of $27.00–$34.56 per hour, depending on factors such as geographic location, education, relevant experience, skills, and internal pay equity.</li><li>
<strong>Remote work:</strong>Opportunity to work remotely within the United States.</li><li>
<strong>Healthcare coverage:</strong>Medical, dental, and vision insurance plans.</li><li>
<strong>Retirement savings:</strong>Access to a 401(k) savings plan.</li><li>
<strong>Paid time off:</strong>Paid time off benefits to support personal needs and work-life balance.</li><li>
<strong>Health savings account (HSA):</strong>Access to an HSA to help manage eligible healthcare expenses.</li><li>
<strong>Flexible spending accounts (FSAs):</strong>Options to set aside funds for eligible healthcare and dependent care expenses.</li><li>
<strong>Financial flexibility:</strong>Access to earned wages before payday through the myFlexPay program.</li><li>
<strong>Disability coverage:</strong>Short-term and long-term disability benefits.</li><li>
<strong>Paid parental leave:</strong>Support for eligible employees welcoming a new child.</li><li>
<strong>Well-being resources:</strong>Access to work-life resources and healthy lifestyle programs.</li><li>
<strong>Inclusive workplace:</strong>A collaborative environment that values diverse perspectives, professional development, and employee well-being.</li>