Senior Specialist, Regulatory Operations (Fully Remote)

Jobgether; United States; Remote; USD 122,000 - 143,000; Full time

Benefits offered by this job

Bonus

Stock options

Remote-first culture

Job summary

Jobgether is partnering with a biopharma company focused on oncology therapies. We seek a Regulatory Operations Specialist to prepare, publish, and deliver high-quality submissions (INDs, CTAs, lifecycle submissions) from a remote US location.

You will drive eCTD publishing, maintain submission plans, and coordinate with document owners to escalate risks promptly. The ideal candidate holds a life sciences degree with at least four years of regulatory operations experience, hands-on eCTD and

Qualifications

• Bachelor's degree in life sciences; 4+ years regulatory operations experience.
• Hands-on eCTD publishing, FDA/ICH standards.
• Experience with RIM systems and managing multiple deliverables.

Responsibilities

• Prepare, publish, and deliver regulatory submissions (INDs/CTAs/lifecycle).
• Maintain submission plans, track milestones, coordinate with document owners, escalate risks.
• Perform document-level QC, resolve publishing issues, support RIM workflows.

Skills

Regulatory ops

eCTD publishing

FDA/ICH standards

Independent delivery

Education

Bachelor’s degree in life sciences

Tools

MS Word

Adobe Acrobat

RIM systems

Job description

• 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.

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.