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Key Responsibilities:
- 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 escalate 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.
Additional Details:
- 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.
Jobgether
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.