Vice President, Regulatory Affairs

Vaga não está no LinkedIn

🕒 Outubro 2

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $280.000 - $340.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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Loyal

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Loyal é uma plataforma digital de saúde líder de ponta a ponta, projetada para unificar os pontos de contato de atendimento para pacientes e provedores. Com foco em melhorar a experiência de saúde por meio da tecnologia, a plataforma integra aprendizado de máquina, processamento de linguagem natural e soluções de gestão de dados líderes do setor. A Loyal oferece ferramentas para gerenciamento de dados de provedores e localizações, engajamento digital, otimização de busca de atendimento, autoagendamento de pacientes, IA conversacional, campanhas de CRM, lembretes de consultas e gestão de reputação. Ela ajuda sistemas de saúde a transformarem suas operações, aumentarem o engajamento dos pacientes e melhorarem os resultados de saúde, garantindo acesso contínuo a informações e processos de atendimento.

Descrição

• Own and drive Loyal's overall regulatory strategy across all active programs, including integrated CMC and clinical regulatory plans from early development through approval and post approval lifecycle management. • Provide regulatory input into portfolio planning, program prioritization, and business development activities. • Develop and maintain global regulatory intelligence capabilities and translate agency expectations, guidance, and industry precedents into actionable strategy. • Provide regulatory updates and risk assessments to executive leadership and the board. • Lead CMC regulatory activities, including filing strategy, CMC section authorship and review, post approval CMC change management, and oversight of manufacturing and CDMO partners. • Partner with CMC and Quality leadership on CDMO regulatory readiness, pre approval inspections, and CMC-related agency interactions. • Lead clinical regulatory activities, including IND strategy and management, protocol regulatory review, study report oversight, and clinical data integration into submissions. • Oversee regulatory strategy for pivotal studies and align study design, endpoints, and agency expectations. • Own approval submission strategy and execution across CMC, Clinical, and Quality, ensuring submission-ready packages reflect agency expectations and eCTD standards. • Serve as Loyal's primary liaison with global regulatory agencies for pre-submission meetings, formal submissions, and ongoing communications. • Manage post approval obligations, including periodic reports, labeling updates, post approval study commitments, and CMC variation filings. • Own labeling strategy and content development throughout the product lifecycle. • Establish and own regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards. • Build and lead a high-performing regulatory organization across CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations. • Establish and scale regulatory governance frameworks and procedural documents for submissions, agency meetings, labeling reviews, and regulatory decisions. • Serve as the independent regulatory authority, escalating risks and compliance concerns to executives. • Foster regulatory excellence and proactive risk management across the organization.

🎯 Requisitos

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or equivalent bio-technical experience and expertise, required. • 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech environments, with 10+ years in senior regulatory leadership roles within sponsor organizations. • Strong CMC regulatory background with deep expertise in small molecule drug development, including OSD formulation, manufacturing process regulatory strategy, CMC section authorship, and post approval change management. • Demonstrated track record of leading regulatory teams spanning both CMC and clinical regulatory functions. • Proven history of successful agency interactions, including pre submission meetings, formal correspondence, and advisory interactions across the product development lifecycle. • Demonstrated experience bringing at least one product to regulatory approval, including NDA, MAA, or equivalent submission leadership. • Required experience with post approval regulatory activities, including CMC change management, labeling updates, periodic safety and annual reports, and post approval study commitments. • Experience building and scaling regulatory organizations in startup or high growth environments. • Strong working knowledge of ICH guidelines and regulatory requirements across relevant global markets. • Executive presence with the ability to serve as the company's primary regulatory authority and represent Loyal credibly with regulatory agencies and senior external stakeholders. • Primary experience in human health pharmaceutical or biotech environments strongly preferred; animal health experience is a plus. • Experience with FDA CVM regulations and the veterinary drug approval pathway (NADA/ANADA), or demonstrated ability to develop expertise in a novel regulatory framework quickly. • Experience filing with and interacting with the EMA and major Asian regulatory agencies (PMDA, NMPA, or equivalents) is a significant plus. • Experience supporting first commercial launches and establishing post approval regulatory infrastructure in a company scaling toward commercialization. • Familiarity with eCTD submission standards and regulatory operations best practices for late stage development companies. • Experience leading organizations through significant growth, transformation, or regulatory milestone events. • Strong systems thinking mindset with a disciplined, risk based approach to regulatory strategy and decision-making.

🏖️ Benefícios

• 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