SR Coordinator Regulatory Submissions Operations

Responsibilities

We are representing a confidential healthcare services organization seeking a Senior Coordinator for their Regulatory Submissions Operations team. This is a fully remote position based in the United States.

In this role, you will utilize specialized technology and knowledge to format, edit, and compile both paper and electronic documents related to pharmaceutical regulatory submissions throughout drug development phases and product life cycles. You will be responsible for:

• Preparing and submitting application files, including specialized electronic formats for drug registrations
• Overseeing and maintaining document management databases for version and revision control
• Assessing project requirements and negotiating realistic timelines
• Managing client documents used in regulatory submissions
• Processing client documents within publishing software platforms
• Identifying potential concerns and communicating proactively with upstream and downstream partners
• Applying advanced skills to resolve complex problems independently
• Potentially providing guidance and technical assistance to less experienced team members

What We're Looking For

• Advanced formatting experience with Microsoft Word documents (required)
• Proven experience formatting and editing Adobe PDF documents (required)
• Working knowledge of Microsoft Excel (required)
• Publishing experience with eCTD (electronic Common Technical Document) preferred
• Project management experience is a strong plus
• Exceptional attention to detail
• Strong written and oral communication skills
• Ability to work independently within established procedures
• Capability to modify processes to resolve unique situations
• Comfort applying knowledge of procedures to complete varied assignments

How We Work with You

Get A Job.ai serves as the exclusive recruiting partner for this confidential client. When you apply through our platform at getajob.ai, our talent team will conduct an initial screening to ensure alignment with the role requirements. If there's a strong match, we will submit your profile to our client for consideration. Please do not attempt to contact the client directly, as all communications must flow through Get A Job.ai to maintain the integrity of the search process.

Pay

Our client has indicated an hourly range of $26.30 - $33.75 USD. This position is not bonus eligible. Compensation is determined by factors including geographical location, relevant education, experience, skills, and internal pay equity considerations.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive recruiting practices. We encourage applications from all qualified candidates regardless of race, religion, color, national origin, age, disability, sex, sexual orientation, gender identity, veteran status, or any other protected characteristic.