SR Coordinator, Regulatory Submission Operations

Accountabilities:

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.
Requirements:
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.
Ability and willingness to learn scientific and pharmaceutical regulatory principles, terminology, and submission requirements.
Exceptional attention to detail, with a strong commitment to accuracy, consistency, document integrity, and quality standards.
Strong written and verbal communication skills, with the ability to coordinate effectively with clients, internal teams, and other stakeholders.
Strong organizational and time management skills, including the ability to assess competing priorities, manage multiple deadlines, and negotiate timelines effectively.
Proven problem-solving abilities and the capacity to work independently within established procedures, exercise sound judgment, and resolve complex issues with minimal supervision.
Ability to adapt to changing requirements, follow established policies, and provide technical support or guidance to colleagues when necessary.
Benefits:
Hourly compensation: 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.
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.
Flexible spending accounts (FSAs): Options to set aside funds for eligible healthcare and dependent care expenses.
Financial flexibility: Access to earned wages before payday through the myFlexPay program.
Disability coverage: Short-term and long-term disability benefits.
Paid parental leave: Support for eligible employees welcoming a new child.
Well-being resources: Access to work-life resources and healthy lifestyle programs.
Inclusive workplace: A collaborative environment that values diverse perspectives, professional development, and employee well-being.