SR Coordinator Regulatory Submissions Operations

Overview

This role is part of Regulatory Submissions Operations, supporting the pharmaceutical regulatory submission process across each phase of drug development and throughout the drug product life cycle. Responsibilities include formatting, editing, and compiling paper and electronic regulatory submission documents, preparing specialized electronic files for drug registrations, and overseeing document management databases to ensure version and revision control.

Location: Remote

Responsibilities

• Use specialized technology and knowledge to format, edit, and compile regulatory submission documents (paper and electronic)
• Prepare specialized electronic files for drug registrations
• Oversee and maintain document management databases for version and revision control
• Assess and negotiate timelines
• Manage client documents used in submissions
• Process client documents within publishing software
• Identify concerns and communicate with upstream and downstream partners

Qualifications

• Experience in advanced formatting of Microsoft Word documents is required
• Experience in formatting and editing Adobe documents is required
• Familiarity with Excel is required
• Publishing experience in eCTD is preferred
• Project management experience is a plus
• Attention to detail
• Strong written and oral communication skills

Expectations at This Level

• Applies knowledge of job and organizational policies and procedures to complete a variety of assignments
• Applies advanced skills to resolve complex problems independently
• May modify processes to resolve situations
• Works independently within established procedures; may receive general guidance on new assignments
• May provide general guidance or technical assistance to less experienced team members

Compensation & Benefits

• Anticipated pay range: $26.30 - $33.75 per hour (USD)
• Bonus eligible: No

Benefits may include:

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Location

Remote

Application Window

Application window anticipated to close: 9/14/26 (submit as soon as possible if interested)

Equal Opportunity

All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status, or any other status protected by federal, state, or local law.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.