[Hiring] Associate Director/Director, Regulatory Operations @Faeth Therapeutics

Role Description

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:

• Planning, managing publishing, and delivery of submissions to FDA and ex-US health authorities with CROs.
• Administration and data integrity of our Regulatory Information Management System (RIMS).
• Submission archive and inspection readiness posture.

The role is deliberately scoped to grow, providing opportunities to move beyond execution into submission strategy, regulatory intelligence, and functional leadership.

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.
  • Apply working knowledge of regional requirements across jurisdictions — FDA eCTD Module 1, EU CTR/CTIS, UK MHRA, Health Canada, and APAC/ROW.
  • Manage electronic dispatch and gateway operations (FDA ESG/Gateway, WebTrader, CESP, CTIS, regional portals).
  • Perform and oversee technical and publishing QC: hyperlinks, bookmarks, granularity, lifecycle operations, PDF rendering, validation criteria, and eCTD backbone integrity.
  • Maintain submission readiness for evolving standards (eCTD v4.0, structured content, regional electronic application form requirements).
• RIMS Ownership & Systems:
  • Serve as business owner and day-to-day administrator of the RIMS platform.
  • Maintain the integrity and completeness of registration, submission, correspondence, and health-authority commitment data.
  • Lead system enhancements, migrations, and releases.
  • Build and maintain dashboards, metrics, and trackers for visibility into submission status, commitments, and cycle times.
  • Develop and maintain SOPs, work instructions, style guides, templates, and document-formatting standards.
• Archival, Records & Inspection Readiness:
  • Own the regulatory archive: official submission-ready copies, health-authority correspondence, and licensing documentation.
  • Ensure archival practices satisfy GxP requirements.
  • Establish and maintain reconciliation processes between the archive, RIMS, the eTMF, and CRO-held records.
• CRO & Vendor Partnership:
  • Act as the primary regulatory operations point of contact for CROs supporting IND and CTA submissions.
  • Manage publishing and regulatory operations vendors.
  • Coordinate with local affiliates, regulatory consultants, and legal representatives in ex-US markets.
  • Partner cross-functionally with Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, and Medical Writing.
• Process, Compliance & Strategic Contribution:
  • Continuously improve regulatory operations processes.
  • Provide regulatory operations input into program planning and submission strategy discussions.
  • Contribute to regulatory intelligence monitoring for operational and electronic-standards changes.
  • Mentor junior staff and contractors.

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.
• Deep, hands-on knowledge of eCTD structure, lifecycle management, and validation.
• Direct experience preparing and submitting INDs and/or CTAs.
• Working proficiency with electronic publishing tools and electronic gateways.
• Demonstrated ownership or administration of a RIMS platform.
• Practical understanding of 21 CFR Part 11, EU Annex 11, ICH guidelines, GxP documentation standards.
• Vendor management experience.
• Advanced document formatting and template skills (MS Word, Adobe Acrobat).
• Communicates clearly and effectively across functions and levels.
• Builds strong cross-functional relationships.
• Proactively identifies challenges and develops practical solutions.
• Curious and proactive about leveraging AI and emerging technologies.

Requirements

• Oncology experience — regulatory operations support for oncology programs.
• Experience supporting or preparing a marketing application (NDA/BLA/MAA).
• RIM administration or configuration experience; eCTD v4.0 readiness work.
• Experience in a small or mid-sized company.
• 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.