Associate Director/Director, Regulatory Operations

The role

This person will own the operational backbone of global regulatory filings. They will plan, manage, and deliver submissions to FDA and ex-US health authorities and administer the Regulatory Information Management System.

What you will do

• Lead end-to-end planning, compilation, publishing, validation, and dispatch of regulatory submissions.
• Own submission-level project plans including timelines and document readiness.
• Apply working knowledge of regional requirements across jurisdictions.
• Manage electronic dispatch and gateway operations.
• Perform and oversee technical and publishing QC.
• Serve as business owner and administrator of the RIMS platform.
• Maintain the integrity and completeness of registration, submission, and correspondence data.
• Lead system enhancements, migrations, and releases.
• Build and maintain dashboards, metrics, and trackers.
• Develop and maintain SOPs, work instructions, style guides, templates, and document-formatting standards.

Required qualifications

• Bachelor's degree in a life science, information science, or related field.
• 8+ years of regulatory operations experience in biotech, pharmaceutical, or CRO/vendor environments.
• Demonstrated ownership of submissions from planning through dispatch.
• Deep, hands-on knowledge of eCTD structure, lifecycle management, and validation.
• Practical experience across US and at least one ex-US region.
• Direct experience preparing and submitting INDs and/or CTAs.
• Working proficiency with electronic publishing tools and with electronic gateways and regional portals.
• Demonstrated ownership or administration of a RIMS platform.
• Practical understanding of 21 CFR Part 11, EU Annex 11, ICH guidelines, GxP documentation standards, and records retention and archival requirements.
• Vendor management experience: scoping, oversight, quality management, and performance accountability.
• Advanced document formatting and template skills (MS Word, Adobe Acrobat).
• Communicates clearly and effectively across functions and levels.

Nice to have

• Oncology experience
• Familiarity with Project Orbis and oncology-specific data expectations is a plus.
• Experience supporting or preparing a marketing application (NDA/BLA/MAA) or a major amendment in a lead operational role.
• RIM administration or configuration experience; eCTD v4.0 readiness work.
• Experience in a small or mid-sized company where regulatory operations is a lean function.
• Experience supporting health-authority inspections or partner audits.
• RAC certification or equivalent.

Benefits

• Competitive salary and equity in a well-funded, clinical-stage biotech
• 100% remote work and flexible schedule
• Health, dental, and vision for you and your dependents
• Flexible time off
• Generous parental leave
• Traditional and Roth 401k
• Mission oriented, remote first culture

Before you apply

• All offers of employment are contingent upon satisfactory completion of a background check and verification of eligibility to work in the United States.

About the company

Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq. They are advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program, toward multiple near-term milestones.