Remote Senior Regulatory Submissions Operations Specialist

Jobgether; United States; Remote; USD 37,000 - 47,000; Full time

Benefits offered by this job

Remote work within the United States

Healthcare coverage

401(k) savings plan

Paid time off

Health savings account (HSA)

Flexible spending accounts (FSAs)

Earned wage access

Disability coverage

Paid parental leave

Well-being resources

Job summary

Jobgether seeks a SR Coordinator, Regulatory Submission Operations in the United States. The role supports regulatory submissions by preparing and formatting essential documentation for pharmaceutical registrations, ensuring quality and timely delivery.

You will work remotely with clients and internal teams, using publishing software to maintain submission integrity. The position emphasizes attention to detail, independence, and the ability to manage multiple priorities while ensuring compliance

Qualifications

• Advanced Microsoft Word formatting for complex documents.
• Experience formatting and editing Adobe documents.
• Proficient Microsoft Excel for data review.
• Experience with QA/QC and SOPs is an advantage.
• Editorial, data analysis, and project management skills preferred.
• Willingness to learn regulatory principles and terminology.
• Excellent attention to detail and document integrity.
• Strong written and verbal communication; capable of coordinating with stakeholders.
• Able to manage multiple priorities with minimal supervision.
• Adapt to changing requirements and provide guidance to colleagues.

Responsibilities

• Coordinate regulatory submission activities, preparing, formatting, editing, and compiling documents.
• Assess project requirements and establish timelines with stakeholders.
• Manage client documentation ensuring completeness and accuracy.
• Process and format client documents using regulatory publishing software.
• Prepare electronic files to support drug registrations and licensing.
• Maintain document management databases with revision tracking and integrity.
• Perform QA/QC checks to identify formatting inconsistencies and compliance concerns.
• Identify issues and coordinate resolutions to minimize delays.
• Apply procedures and technical expertise to resolve complex documentation challenges.
• Provide guidance to junior team members and contribute to process improvements.

Skills

Word formatting

Adobe editing

Excel

QA/QC SOPs

Editorial

Data analysis

Project management

Regulatory principles

Attention to detail

Communication

Time management

Independent work

Adaptability

Job description

Jobgether seeks a SR Coordinator, Regulatory Submission Operations in the United States. The role supports regulatory submissions by preparing and formatting essential documentation for pharmaceutical registrations, ensuring quality and timely delivery.

You will work remotely with clients and internal teams, using publishing software to maintain submission integrity. The position emphasizes attention to detail, independence, and the ability to manage multiple priorities while ensuring compliance