Senior Specialist, Regulatory Operations; Fully Remote

• Prepare, publish, and deliver high-quality regulatory submissions for oncology therapies, including INDs, CTAs, and lifecycle submissions.
• Maintain submission plans, track milestones, coordinate with document owners, and escalation risks promptly.
• Perform document-level technical QC, resolve publishing issues, and support RIM workflows and system changes.

Required Experience:

• Bachelor’s degree in life sciences and at least 4 years of regulatory operations experience in pharma or biotech.
• Hands-on eCTD publishing, FDA/ICH standards, and strong MS Word and Adobe Acrobat skills.
• Experience with RIM systems and the ability to manage multiple deliverables independently.
• Remote position within the United States with an annual salary range of $122,000-$143,000.
• Total compensation may include bonus, stock, and other benefits.
• Applications are reviewed via Jobgether’s AI-powered matching process.

A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.