Director, Regulatory Affairs – Clinical

Emploi pas sur LinkedIn

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $155 000 - $205 000 / an

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Loyal

Site WebLinkedInTous les Emplois

51 - 200 employés

⚕️ Assurance santé

🤖 Intelligence artificielle

☁️ SaaS

Healthcare Insurance • Artificial Intelligence • SaaS

Loyal est une plateforme de santé numérique de bout en bout, conçue pour unifier les points de contact des soins pour les patients et les prestataires. Avec un accent sur l'amélioration de l'expérience de soins de santé grâce à la technologie, la plateforme intègre l'apprentissage machine, le traitement du langage naturel et des solutions de gestion de données de pointe. Loyal propose des outils pour gérer les données des prestataires et des lieux, l'engagement numérique, l'optimisation des recherches de soins, l'auto-planification des patients, l'IA conversationnelle, les campagnes CRM, les rappels de rendez-vous et la gestion de la réputation. Elle aide les systèmes de santé à transformer leurs opérations, à renforcer l'engagement des patients et à améliorer les résultats de santé en garantissant un accès sans faille aux informations et procédures de soins.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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