Director, Regulatory Affairs – Clinical

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🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

💵 $155.000 - $205.000 / Jahr

⏰ Vollzeit

🔴 Experte

🚔 Compliance

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Loyal

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

⚕️ Krankenversicherung

🤖 Künstliche Intelligenz

☁️ SaaS

Healthcare Insurance • Artificial Intelligence • SaaS

Loyal ist eine führende, ganzheitliche digitale Gesundheitsplattform, die darauf ausgelegt ist, Versorgungsschnittstellen für Patienten und Anbieter zu vereinen. Mit dem Ziel, das Gesundheitswesen durch Technologie zu verbessern, integriert die Plattform maschinelles Lernen, natürliche Sprachverarbeitung und branchenführende Datenmanagementlösungen. Loyal bietet Werkzeuge zur Verwaltung von Anbietern und Standortdaten, digitalem Engagement, Optimierung der Versorgungssuche, Patienten-Selbstterminierung, KI-gesteuerten Gesprächen, CRM-Kampagnen, Terminerinnerungen und Reputationsmanagement. Sie hilft Gesundheitssystemen, ihre Abläufe zu transformieren, die Patientenbindung zu verbessern und Gesundheitsergebnisse zu optimieren, indem sie nahtlosen Zugang zu Versorgungsinformationen und -prozessen gewährleistet.

Beschreibung

• Authoring and reviewing regulatory submissions, including INAD filings, study reports, clinical trial evaluability meetings, and agency correspondence • Leading preparation for FDA CVM meetings, including  briefing documents, meeting requests, posing questions, and follow-up MOCs • Partnering with clinical teams to provide real-time regulatory guidance on active studies, including SAE submissions, BIMO preparedness, and NCIE reports • Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest quality submissions for pivotal protocol concurrence • Monitoring and interpreting CVM guidance, policy updates, and precedent to inform Loyal's regulatory strategy across our pipeline • Anticipating and resolving regulatory risks across functions (including R&D, CMC, and commercial) throughout the portfolio before they become problems • Managing and mentoring 1–2 direct reports, providing feedback, priorities, and development support • Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and legal teams on submissions and strategy • Oversee the maintenance and organization of all regulatory records and interactions related to Loyal’s drug programs • Serving as the internal subject matter expert for any question touching FDA CVM clinical requirements — from study design to labeling to adverse event reporting • Reviewing and advising on external facing pre-approval communications and activities to ensure compliance with FDA CVM regulations • Reviewing and providing guidance on labeling materials for submission to ensure compliance with FDA CVM regulations

🎯 Anforderungen

• Bachelor’s degree in relevant field (biology, vet med, regulatory affairs or related); relevant experience > specific degree • 10+ years of regulatory affairs experience in animal health with direct experience with owning FDA CVM relationships • Hands on ownership experience with INADs, regulatory submissions, and FDA CVM in-person meetings • Background across multiple drug types ideal (small molecules, biologics, injectables, etc.) • You are data-driven and an analytical thinker; your regulatory experience is grounded in evidence and you communicate with excellence • Strong and experienced writer that takes pride in clarity, accuracy and persuasive story telling about biological pathways or drug mechanisms and clinical impacts • Extensive knowledge of FDA CVM regulatory pathways, policies, and limitations and where there are areas to innovate within those bounds • Excellent judgement where FDA CVM is concerned and comfortable being the single source of strategic conviction using that judgement • Collaborative with cross-functional teams and not afraid to be in the weeds while also being the subject matter expert • Ability to operate as a high level individual contributor while also serving as a mentor to junior team members in order to upskill the department. • Energized by a fast-paced startup environment

🏖️ Vorteile

• Full-coverage health insurance — medical, dental and vision — for you and your dependents • $1,000 home office equipment stipend • $1,200/year learning budget for books, courses, etc. • $250/month wellness budget for gym, cleaners, spa, food, etc. • All 3-day weekends are turned into 4-day weekends 🎉 • Unlimited vacation and paid holidays • Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶 • Competitive salary • Company equity options grant for new hires