Manager – Regulatory Affairs

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🕒 Outubro 16

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 22%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 25 dias.
• Sem salário divulgado.

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Prolerity Clinical Research

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🏥 Saúde

🧬 Biotecnologia

☁️ SaaS

Healthcare • Biotechnology • SaaS

A Prolerity Clinical Research é uma rede de sites de pesquisa clínica sediada nos Estados Unidos, que opera clínicas de pesquisa em diversos estados (Louisiana, Flórida, Nova Jersey, Nova York). A empresa conduz ensaios clínicos de fase I a IV em uma ampla variedade de áreas terapêuticas, incluindo distúrbios hepáticos (MASH/MASLD), cardiometabólico, SNC, vacinas, otorrinolaringologia, respiratório, dermatologia, enxaquecas, gastroenterologia, dor aguda/crônica/neuropática, neurologia, cognição/demência e medicina geral. A Prolerity foca no recrutamento de pacientes, na coleta de dados de alta qualidade, no cuidado ao paciente e no atendimento a diversas comunidades. Ela se posiciona como uma parceira para patrocinadores farmacêuticos e de biotecnologia que necessitam de redes de sites eficientes, capazes de recrutamento rápido e início de estudos.

Descrição

• Lead the centralized regulatory function for Prolerity Clinical Research’s multisite clinical-trial network • Manage regulatory staff and own regulatory readiness from site selection through activation, study maintenance, and closeout • Provide hands-on oversight of daily regulatory work, submissions, document review, and issue resolution • Lead regulatory startup, establish study ownership and timelines, and define submission responsibilities • Prepare and quality-check regulatory packets, including Form FDA 1572 or investigator agreements, CVs, licenses, training records, financial disclosures, and localized informed consent forms • Coordinate sponsor review and Central IRB submissions; track approvals, outstanding documents, and activation dependencies • Partner with investigators, site leadership, clinical operations, contracts and budgets, sponsors, CROs, and Central IRBs to resolve startup barriers • Verify approvals, training, documentation, and sponsor authorization before participant consent and study activities begin • Manage amendments through submission and implementation, including document distribution, staff training, re-consent, and version retirement • Coordinate regulatory requirements for investigator transitions and study staff changes • Oversee safety submissions, reportable events, continuing reviews, IRB correspondence, study closeout, and record retention • Track credential and document expirations and obtain updates before lapse • Conduct regulatory quality reviews and support monitoring visits, sponsor audits, and FDA inspections • Lead corrective and preventive actions for regulatory findings • Coordinate qualification, agreements, and regulatory documentation for external laboratories, imaging centers, and outsourced providers • Maintain central laboratory, imaging, and sponsor-vendor documentation • Supervise, coach, and develop regulatory specialists; balance workloads and manage performance • Provide onboarding and continuing training and maintain SOPs, templates, checklists, and sponsor-specific guidance • Oversee regulatory communications, study trackers, and electronic regulatory systems • Report cycle times, blocked items, document completeness, and compliance trends to leadership • Implement measurable process improvements and establish consistent startup and training workflows

🎯 Requisitos

• More than five years of site-side clinical trial regulatory experience at an investigative site, site network, or site management organization • Startup ownership for industry-sponsored drug studies • At least three years of leadership experience, including staff supervision, coaching, workload management, and accountability for results • Hands-on experience with Central IRB submissions, consent localization, essential regulatory documents, and amendment management • Strong working knowledge of applicable FDA requirements, ICH Good Clinical Practice, and human subject protections • Experience coordinating documentation for laboratories, imaging centers, or other outsourced study procedures • Experience developing regulatory processes adopted by a team • Strong communication, organizational, and problem-solving skills • Ability to manage competing priorities remotely • Ability to travel approximately 20% • Experience with CRIO, Complion, and other electronic regulatory or investigator site file systems preferred • Experience supporting medical device studies, a multisite or multistate network, and sponsor audits or FDA inspections preferred • Bachelor’s degree in a life science or related field, or equivalent relevant experience • ACRP or SOCRA certification preferred • RAPS RAC certification is a plus

🏖️ Benefícios

• Fully remote work arrangement • Approximately 20% travel to sites across the South, Southeast, and Northeast • Training and continuing development opportunities • Staff coaching and professional development • Leadership responsibility and process improvement ownership

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