SR Coordinator, Regulatory Submission Operations

OpenKrill; United States; Remote; USD 37,000 - 48,000; Full time

Benefits offered by this job

Hourly compensation: $27.00–$34.56 per

Remote work within United States

Healthcare coverage (medical, dental,視

401(k) retirement savings

Paid time off

Health savings account (HSA)

Flexible spending accounts (FSAs)

Earned wages access (myFlexPay)

Disability coverage

Paid parental leave

Well-being resources

Inclusive workplace

Job summary

OpenKrill seeks a SR Coordinator, Regulatory Submission Operations to support pharmaceutical regulatory submissions from a remote environment in the United States. You will prepare, format, edit, and compile essential documents, ensure quality standards, and meet timelines while coordinating with clients and internal teams.

The role emphasizes meticulous attention to detail, independence, and the ability to manage multiple priorities, using specialized publishing software and document management

Qualifications

• Proficiency with advanced Microsoft Word document formatting for complex structures.
• Experience formatting and editing Adobe documents for submission-ready files.
• Proficient Excel skills to manage data and workflows.
• Experience with QA, QC, and SOPs is advantageous.
• Editorial, data analysis, and project management experience preferred.
• Willingness to learn pharmaceutical regulatory principles and terminology.

Responsibilities

• Coordinate regulatory submission activities, including preparing, formatting, editing, and compiling documents for pharmaceutical regulatory applications.
• Establish timelines, negotiate deadlines with stakeholders, and ensure timely submission delivery.
• Manage client-provided documentation, ensuring files are complete, accurate, and organized for processing.
• Process and format client documents using regulatory publishing software and ensure compliance with submission specs.
• Prepare electronic files for drug registrations, listings, licenses, renewals, and other submission activities.
• Maintain document management databases with version control and integrity throughout submissions.
• Perform QA/QC checks to identify formatting issues and potential compliance concerns prior to submission.
• Identify issues, communicate with upstream/downstream partners, and coordinate resolutions to minimize delays.
• Provide guidance to less experienced team members and contribute to process improvements.

Skills

Word formatting

Adobe formatting

Excel

QA/QC SOPs

Project management

Editorial experience

Data analysis

Regulatory principles

Job description

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.

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.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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