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About the Role
Faeth Therapeutics is a clinical-stage oncology company seeking an Associate Director, Regulatory Operations to manage the operational aspects of global regulatory filings. This role involves planning, publishing, and delivering submissions to health authorities, managing the Regulatory Information Management System (RIMS), and ensuring submission archive and inspection readiness. The position offers growth opportunities into submission strategy, regulatory intelligence, and leadership.
Responsibilities
- Lead end-to-end planning, compilation, publishing, validation, and dispatch of regulatory submissions (INDs, CTAs, amendments, annual reports, briefing packages, etc.).
- Own submission-level project plans, including content collection timelines, document readiness tracking, publishing windows, QC cycles, and dispatch dates.
- Apply knowledge of regional regulatory requirements (FDA eCTD Module 1, EU CTR/CTIS, UK MHRA, Health Canada, APAC/ROW) and provide guidance.
- Manage electronic dispatch and gateway operations (FDA ESG/Gateway, WebTrader, CESP, CTIS, regional portals).
- Perform and oversee technical and publishing QC, ensuring resolution of validation errors before dispatch.
- Maintain submission readiness for evolving standards (eCTD v4.0, structured content, regional electronic application form requirements).
- Serve as business owner and administrator of the RIMS platform, managing configuration, user access, and data integrity.
- Lead system enhancements, migrations, and releases, ensuring compliance with 21 CFR Part 11 and EU Annex 11.
- Build and maintain dashboards and metrics for visibility into submission status and cycle times.
- Develop and maintain SOPs, work instructions, style guides, and templates.
- Own the regulatory archive, ensuring compliance with GxP requirements and retrieval procedures.
- Support inspection preparation, requests, and responses.
- Establish and maintain reconciliation processes between the archive, RIMS, eTMF, and CRO records.
- Act as the primary regulatory operations point of contact for CROs supporting submissions.
- Manage publishing and regulatory operations vendors, including scope of work, SLAs, and performance.
- Coordinate with local affiliates, consultants, and legal representatives for ex-US documentation.
- Partner cross-functionally with Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, and Medical Writing.
- Continuously improve regulatory operations processes, identifying opportunities for automation and efficiency.
- 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, with potential for future people management.
Requirements
- 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 across US and at least one ex-US region.
- Direct experience preparing and submitting INDs and/or CTAs, including work with CROs or partners.
- Working proficiency with electronic publishing tools and electronic gateways/portals.
- Demonstrated ownership or administration of a RIMS platform, including data integrity, reporting, and system release/UAT.
- Practical understanding of 21 CFR Part 11, EU Annex 11, ICH guidelines, GxP documentation standards, and records retention/archival requirements.
- Vendor management experience: scoping, oversight, quality management, and performance accountability.
- Advanced document formatting and template skills (MS Word, Adobe Acrobat).
- Ability to diagnose technical publishing issues without immediate escalation.
- Clear and effective communication across functions and levels.
- Ability to build strong cross-functional relationships and work effectively with internal teams, external partners, and vendors.
- Proactive problem-solving skills.
- Curiosity and proactivity in leveraging AI and emerging technologies.
Skills
- Regulatory Operations
- Submission Management
- Publishing
- Regulatory Information Management System (RIMS)
- eCTD
- IND submissions
- CTA submissions
- FDA ESG/Gateway
- Vendor Management
- GxP
- 21 CFR Part 11
- EU Annex 11
- ICH guidelines
- MS Word
- Adobe Acrobat
- AI
- Emerging Technologies
Location
- Remote (U.S.)
Work Type
- Remote
- Full-time
Experience Level
- Associate Director
- 8+ years regulatory operations experience
Education Level
- Bachelor's degree in a life science, information science, or related field
Salary/Compensations
- $155,000 - $220,000
Benefits
- Competitive salary and equity
- 100% remote work
- Flexible schedule
- Health, dental, and vision for employee and dependents
- Flexible time off
- Generous parental leave
- Traditional and Roth 401k
- Mission oriented, remote first culture
About the Company
- Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq.
- Recently raised $200M in funding.
- Strong scientific foundation with a founding team including the discoverer of the target pathway.
- Advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program.
- Small, focused team where every person has direct impact.
- United by a shared commitment to care deeply, create boldly, and never stop learning.
Equal Opportunity
- We are an equal opportunity employer, and we value diversity at our company.
- We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
- All offers of employment are contingent upon satisfactory completion of a background check and verification of eligibility to work in the United States.