Associate Director/Director, Regulatory Operations

About this role

Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M in funding. With a strong scientific foundation and a founding team that includes the discoverer of our target pathway, we are advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program, toward multiple near-term milestones. We are a small, focused team where every person has direct impact — united by a shared commitment to care deeply, create boldly, and never stop learning.

We are seeking an Associate Director, Regulatory Operations to own the operational backbone of our global regulatory filings. This is a hands-on, high-ownership role responsible for the planning, and manage publishing, and delivery of submissions to FDA and ex-US health authorities with CROs,, for the administration and data integrity of our Regulatory Information Management System (RIMS), for our submission archive and inspection readiness posture

The role is deliberately scoped to grow. As our pipeline advances within the clinical development stages ultimately towards registration, the person in this seat will have the opportunity to move beyond execution into submission strategy, regulatory intelligence, and functional leadership — shaping how the regulatory organization operates rather than only running it.

Reports to: VP, Regulatory Affairs

Location: Remote (U.S.)

Responsibilities:

Submission Management & Publishing (US and ex-US)

• Lead end-to-end planning, compilation, publishing, validation, and dispatch of regulatory submissions, including INDs, CTAs, amendments, annual reports/DSURs, briefing packages, meeting requests, orphan drug and expedited-pathway applications, and future MAA/NDA/BLA content.

• Own submission-level project plans: content collection timelines, document readiness tracking, publishing windows, QC cycles, and dispatch dates. Escalate risks early with options, not just status.

• Apply working knowledge of regional requirements across jurisdictions — FDA eCTD Module 1, EU CTR/CTIS, UK MHRA, Health Canada, and APAC/ROW as the portfolio requires — and translate those differences into actionable guidance for authors and study teams.

• Manage electronic dispatch and gateway operations (FDA ESG/Gateway, WebTrader, CESP, CTIS, regional portals), including account administration, certificates, test submissions, and troubleshooting failed transmissions.

• Perform and oversee technical and publishing QC: hyperlinks, bookmarks, granularity, lifecycle operations, PDF rendering, validation criteria, and eCTD backbone integrity. Own resolution of validation errors before dispatch.

• Maintain submission readiness for evolving standards (eCTD v4.0, structured content, regional electronic application form requirements) and lead the organization's preparedness work.

RIMS Ownership & Systems

• Serve as business owner and day-to-day administrator of the RIMS platform including configuration requests, user access and training, controlled vocabularies, and document/record lifecycles.

• Maintain the integrity and completeness of registration, submission, correspondence, and health-authority commitment data so that the system is a trusted source of truth for reporting and inspection.

• Lead system enhancements, migrations, and releases: requirements gathering, vendor coordination in line with 21 CFR Part 11, EU Annex 11, and internal computer system validation procedures.

• Build and maintain dashboards, metrics, and trackers that give Regulatory, Clinical Development, and Program Management visibility into submission status, commitments, and cycle times.

• Develop and maintain SOPs, work instructions, style guides, templates, and document-formatting standards; train authors and study teams on their use.

Archival, Records & Inspection Readiness

• Own the regulatory archive: official submission-ready copies, health-authority correspondence and meeting minutes, approvals, and licensing documentation, with defined retention periods and retrieval procedures.

• Ensure archival practices satisfy GxP requirements and are defensible in an FDA or EU inspection or partner audit; support inspection preparation, requests, and responses.

• Establish and maintain reconciliation processes between the archive, RIMS, the eTMF, and CRO-held records so that ownership of records is unambiguous at study close-out.

CRO & Vendor Partnership

• Act as the primary regulatory operations point of contact for CROs supporting IND and CTA submissions: define deliverables and formats, align on timelines, review incoming documents for submission readiness, and drive issue resolution.

• Manage publishing and regulatory operations vendors — scope of work, SLAs, budgets and accruals, capacity planning, quality oversight, and performance reviews. Hold vendors accountable to agreed quality and turnaround standards.

• Coordinate with local affiliates, regulatory consultants, and legal representatives in ex-US markets to secure country-specific documents (legalized/notarized documents, GMP certificates, IB translations, labeling) on the critical path.

• Partner cross-functionally with Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, and Medical Writing to secure submission content on schedule and to the right standard.

Process, Compliance & Strategic Contribution

• Continuously improve regulatory operations processes, identifying where automation, templates, or better upstream discipline reduce cycle time and rework.

• Provide regulatory operations input into program planning and submission strategy discussions, including feasibility, sequencing, and resourcing implications of proposed filing plans.

• Contribute to regulatory intelligence monitoring for operational and electronic-standards changes, and advise leadership on impact and required action.

• Mentor junior staff and contractors; as the function grows, take on direct people management.

Requirements:

• Bachelor's degree in a life science,…