Associate Director/Director, Regulatory Operations

🕒 Outubro 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $155.000 - $220.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Faeth Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🧬 Biotecnologia

💊 Farmacêutico

🔥 Investimento no último ano

💰 $200.000.000 Merger/Acquisition em 2026-02

Biotechnology • Pharmaceuticals

A Faeth Therapeutics é uma empresa de biotecnologia em estágio clínico que desenvolve inibidores orais de múltiplos nós da via PAM (PI3K/AKT/mTOR) para oncologia. Seu principal candidato, o PIKTOR, é uma combinação totalmente oral desenvolvida para inibir simultaneamente PI3K-alfa, mTORC1 e mTORC2, com o objetivo de alcançar uma supressão mais profunda da via e reduzir os mecanismos de escape tumoral. O PIKTOR está sendo avaliado em diversas indicações de câncer (incluindo câncer endometrial e câncer de mama HR+/HER2-) em estudos de Fase 1 e Fase 2. A empresa prioriza uma formulação oral para reduzir os impactos relacionados a infusões e concentra-se no desenvolvimento de novas terapias para melhorar os resultados de pacientes com cânceres de difícil tratamento. Os candidatos a medicamentos são investigacionais e não foram aprovados pelas autoridades regulatórias.

Descrição

• Own the operational backbone of global regulatory filings and report to the VP, Regulatory Affairs • Lead end-to-end planning, compilation, publishing, validation, and dispatch of 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 with options • Apply regional requirements across FDA eCTD Module 1, EU CTR/CTIS, UK MHRA, Health Canada, and APAC/ROW jurisdictions • Manage electronic dispatch and gateway operations, including FDA ESG/Gateway, WebTrader, CESP, CTIS, and regional portals • Perform and oversee technical and publishing QC, including hyperlinks, bookmarks, granularity, lifecycle operations, PDF rendering, validation criteria, and eCTD backbone integrity • Maintain readiness for eCTD v4.0, structured content, and regional electronic application-form requirements • Serve as business owner and day-to-day administrator of the RIMS platform • Maintain registration, submission, correspondence, and health-authority commitment data integrity • Lead system enhancements, migrations, and releases, including requirements gathering, vendor coordination, and validation compliance • Build dashboards, metrics, and trackers for submission status, commitments, and cycle times • Develop and maintain SOPs, work instructions, style guides, templates, and document-formatting standards; train authors and study teams • Own the regulatory archive and ensure inspection-ready retention and retrieval of submissions, correspondence, approvals, and licensing documentation • Establish reconciliation processes among the archive, RIMS, eTMF, and CRO-held records • Act as primary regulatory-operations contact for CROs; define deliverables, align timelines, review documents, and resolve issues • Manage publishing and regulatory-operations vendors, including scopes, SLAs, budgets, capacity, quality oversight, and performance reviews • Coordinate with affiliates, consultants, and legal representatives to secure country-specific ex-US documents • Partner with Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, and Medical Writing teams • Continuously improve processes through automation, templates, and upstream discipline • Contribute regulatory-operations input to program planning, submission strategy, regulatory intelligence, and operational/electronic-standards monitoring • Mentor junior staff and contractors, with potential for direct people management as the function grows

🎯 Requisitos

• 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, including demonstrated ownership of submissions from planning through dispatch • Deep, hands-on knowledge of eCTD structure, lifecycle management, and validation, with practical experience across US and at least one ex-US region • Direct experience preparing and submitting INDs and/or CTAs, including work with CROs or partners on clinical trial applications • Working proficiency with electronic publishing tools and with electronic gateways and regional portals • Demonstrated ownership or administration of a RIMS platform, including data integrity, reporting, and system release/UAT activities • 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) and comfort diagnosing technical publishing issues without escalating first • Communicates clearly and effectively across functions and levels, tailoring messaging to the audience and keeping key stakeholders informed • Builds strong cross-functional relationships and works effectively with internal teams, external partners, and vendors to achieve shared goals • Proactively identifies challenges and develops practical, thoughtful solutions rather than waiting for direction • Curious and proactive about leveraging AI and emerging technologies to improve efficiency, streamline workflows, and enhance the quality of work • Background check and verification of eligibility to work in the United States required • Nice to have: oncology experience; experience supporting or preparing an NDA/BLA/MAA or major amendment; RIM administration/configuration; eCTD v4.0 readiness; small or mid-sized company experience; health-authority inspection or partner-audit experience; RAC certification or equivalent

🏖️ Benefícios

• 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

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