Senior Regulatory Submissions Specialist — Remote

Jobgether; Oregon; Hybrid; USD 122,000 - 143,000; Full time

Benefits offered by this job

Remote work within the United States

Job summary

Jobgether is seeking a Senior Specialist, Regulatory Operations in the United States. You will manage regulatory submissions, coordinate with cross-functional teams, and ensure timely delivery of complex filings across global programs.

The role emphasizes eCTD publishing, RIM systems, and document quality control, with remote work within the US and a compensation range aligned to experience.

Qualifications

• Bachelor's degree in life sciences or a related discipline.
• Master's degree in Regulatory Affairs is highly desirable.
• At least 4 years of regulatory operations experience including eCTD publishing.
• Experience with RIM or a validated document management platform.

Responsibilities

• Manage routine regulatory submissions including INDs, CTAs, and meeting packages.
• Prepare submission-ready Word and PDF documents with quality checks.
• Publish and validate eCTD and non-eCTD submission packages.
• Coordinate with document owners to track content handoffs and actions.
• Maintain regulatory records and Milestones in Veeva RIM (or similar).
• Support cross-functional teams to ensure timely regulatory deliverables.

Skills

Attention to detail

Project coordination

Risk communication

Independent work

Education

Bachelor's degree in life sciences or related discipline

Master's degree in Regulatory Affairs (desirable)

Tools

Microsoft Word

Adobe Acrobat

Regulatory Information Management (RIM) system

Job description

Jobgether is seeking a Senior Specialist, Regulatory Operations in the United States. You will manage regulatory submissions, coordinate with cross-functional teams, and ensure timely delivery of complex filings across global programs.

The role emphasizes eCTD publishing, RIM systems, and document quality control, with remote work within the US and a compensation range aligned to experience.