{"id":1297097,"url":"https://alion.io/job/faeth-therapeutics-associate-directordirector-regulatory-operations","title":"Associate Director/Director, Regulatory Operations","company":{"id":3786270,"name":"Faeth Therapeutics","domain":"faeththerapeutics.com","url":"https://alion.io/company/faeththerapeutics","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":155000,"max":220000,"currency":"USD","period":"year","gross":null,"usd_annual":220000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-22T19:10:23Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-11-01T07:56:24Z","board_verified":true,"closed_at":null,"days_open":39,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":39},"description":"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.\nWe 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\nThe 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.\nReports to: VP, Regulatory Affairs\nLocation: Remote (U.S.)\nResponsibilities:\nSubmission Management & Publishing (US and ex-US)\nLead 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.\nOwn 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.\nApply 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.\nManage electronic dispatch and gateway operations (FDA ESG/Gateway, WebTrader, CESP, CTIS, regional portals), including account administration, certificates, test submissions, and troubleshooting failed transmissions.\nPerform 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.\nMaintain submission readiness for evolving standards (eCTD v4.0, structured content, regional electronic application form requirements) and lead the organization's preparedness work.\nRIMS Ownership & Systems\nServe 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.\nMaintain 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.\nLead 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.\nBuild and maintain dashboards, metrics, and trackers that give Regulatory, Clinical Development, and Program Management visibility into submission status, commitments, and cycle times.\nDevelop and maintain SOPs, work instructions, style guides, templates, and document-formatting standards; train authors and study teams on their use.\nArchival, Records & Inspection Readiness\nOwn the regulatory archive: official submission-ready copies, health-authority correspondence and meeting minutes, approvals, and licensing documentation, with defined retention periods and retrieval procedures.\nEnsure archival practices satisfy GxP requirements and are defensible in an FDA or EU inspection or partner audit; support inspection preparation, requests, and responses.\nEstablish 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.\nCRO & Vendor Partnership\nAct 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.\nManage 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.\nCoordinate 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.\nPartner cross-functionally with Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, and Medical Writing to secure submission content on schedule and to the right standard.\nProcess, Compliance & Strategic Contribution\nContinuously improve regulatory operations processes, identifying where automation, templates, or better upstream discipline reduce cycle time and rework.\nProvide regulatory operations input into program planning and submission strategy discussions, including feasibility, sequencing, and resourcing implications of proposed filing plans.\nContribute to regulatory intelligence monitoring for operational and electronic-standards changes, and advise leadership on impact and required action.\nMentor junior staff and contractors; as the function grows, take on direct people management.\nRequirements:\nBachelor's degree in a life science, information science, or related field.\n8+ years of regulatory operations experience in biotech, pharmaceutical, or CRO/vendor environments, including demonstrated ownership of submissions from planning through dispatch.\nDeep, hands-on knowledge of eCTD structure, lifecycle management, and validation, with practical experience across US and at least one ex-US region.\nDirect experience preparing and submitting INDs and/or CTAs, including work with CROs or partners on clinical trial applications.\nWorking proficiency with electronic publishing tools and with electronic gateways and regional portals.\nDemonstrated ownership or administration of a RIMS platform, including data integrity, reporting, and system release/UAT activities.\nPractical understanding of 21 CFR Part 11, EU Annex 11, ICH guidelines, GxP documentation standards, and records retention and archival requirements.\nVendor management experience: scoping, oversight, quality management, and performance accountability.\nAdvanced document formatting and template skills (MS Word, Adobe Acrobat) and comfort diagnosing technical publishing issues without escalating first.\nCommunicates clearly and effectively across functions and levels, tailoring messaging to the audience and keeping key stakeholders informed.\nBuilds strong cross-functional relationships and works effectively with internal teams, external partners, and vendors to achieve shared goals.\nProactively identifies challenges and develops practical, thoughtful solutions rather than waiting for direction.\nCurious and proactive about leveraging AI and emerging technologies to improve efficiency, streamline workflows, and enhance the quality of work.\nNice to have:\nOncology experience - regulatory operations support for oncology programs, including the operational demands of expedited pathways (Fast Track, Breakthrough Therapy, RMAT, PRIME), adaptive or basket/umbrella trial designs, frequent protocol amendments, and parallel multi-region CTA submissions. Familiarity with Project Orbis and oncology-specific data expectations is a plus.\nExperience supporting or preparing a marketing application (NDA/BLA/MAA) or a major amendment in a lead operational role.\nRIM administration or configuration experience; eCTD v4.0 readiness work.\nExperience in a small or mid-sized company where regulatory operations is a lean function and processes must be built rather than inherited.\nExperience supporting health-authority inspections or partner audits.\nRAC certification or equivalent.\nCompensation Range: $155,000 - $220,000 (actual compensation may vary based on experience, qualifications and location)\nWorking at Faeth\nBenefits:\nCompetitive salary and equity in a well-funded, clinical-stage biotech\n100% remote work and flexible schedule\nHealth, dental, and vision for you and your dependents\nFlexible time off\nGenerous parental leave\nTraditional and Roth 401k \nMission oriented, remote first culture\nWe 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.\nAll offers of employment are contingent upon satisfactory completion of a background check and verification of eligibility to work in the United States.","description_format":"text","description_chars":9250,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Equity","Flexible schedule","Flexible time off","Parental leave"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-26T09:50:35Z"}],"visa":[],"liveness":{"score":47,"band":"ok","label":"Likely open","p_open":1,"p_active":0.86,"p_room":0.55,"age_days":39,"expected_fill_days":39,"reasons":["conf:2","win:tail"],"computed_at":"2026-11-01T06:10:25Z"},"pay":{"stated_usd_annual":220000,"is_top_pay":false},"html_url":"https://alion.io/job/faeth-therapeutics-associate-directordirector-regulatory-operations","json_url":"https://alion.io/job/faeth-therapeutics-associate-directordirector-regulatory-operations.json","meta":{"generated_at":"2026-11-01T08:14:44Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":12861,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":3786270},"rest":"https://alion.io/mcp/rest/get_company?id=3786270"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ffaeth-therapeutics-associate-directordirector-regulatory-operations"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Ffaeth-therapeutics-associate-directordirector-regulatory-operations"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Ffaeth-therapeutics-associate-directordirector-regulatory-operations"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/faeth-therapeutics-associate-directordirector-regulatory-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ffaeth-therapeutics-associate-directordirector-regulatory-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1297097}},{"tool":"search_jobs","arguments":{"company":"faeththerapeutics.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1297097},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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