Senior Small Molecule Regulatory Affairs – Compliance Subject Matter Expert

Vaga não está no LinkedIn

🕒 Outubro 29

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 12%

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 12 dias.
• Sem salário divulgado.

Candidatar-se

Encontrar Vagas Remotas Similares

Tunnell Consulting, Inc.

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 1962

🏛️ Governo

🏥 Saúde

💼 Consultoria

Government • Healthcare • Consulting

A Tunnell Consulting, Inc. é uma empresa de consultoria e serviços com foco no governo, que oferece expertise científica, técnica e em gestão de projetos para agências federais. As soluções da empresa (sob a marca Tunnell Government Services) são voltadas à preparação e à resposta em saúde pública — ajudando a proteger os Estados Unidos contra grandes ameaças à saúde — e à gestão estratégica de portfólios de projetos científicos em todas as fases de P&D, incluindo o desenvolvimento de produtos médicos e a supervisão de portfólios. A empresa também oferece soluções de staffing para apoiar clientes governamentais e transformar organizações para que cumpram suas missões institucionais.

Descrição

• Provide strategic regulatory expertise, program management support, and technical guidance for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR®) initiative and related pharmaceutical manufacturing programs • Serve as the Federal Government's regulatory expert for FDA-regulated small-molecule drug products • Provide oversight and guidance regarding regulatory strategy, ANDA/NDA submissions, CMC development, manufacturing compliance, approval pathways, and lifecycle management • Serve as Regulatory Subject Matter Expert for small-molecule generic drug development, manufacturing, and approval programs • Provide scientific, technical, and regulatory guidance for assigned programs and projects • Review and assess contractor and partner regulatory strategies, timelines, and submission plans • Support and evaluate FDA interactions • Assess regulatory risks and recommend mitigation strategies • Monitor evolving FDA regulations, guidance documents, and industry expectations • Review and provide guidance on FDA submissions • Support data-driven submission strategies for efficient FDA review and approval • Evaluate submission readiness and regulatory documentation • Assess CMC strategies for API and drug product programs • Review manufacturing development plans, technology transfer strategies, validation programs, and commercial manufacturing readiness • Conduct regulatory research, intelligence gathering, and competitive landscape assessments • Monitor trends in generic drug approvals, manufacturing regulations, and supply chain resiliency initiatives • Serve as regulatory representative on multidisciplinary teams supporting strategic pharmaceutical manufacturing initiatives • Collaborate with Government leadership, pharmaceutical manufacturers, CDMOs, regulatory agencies, quality organizations, and technical teams

🎯 Requisitos

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, Biology, Regulatory Affairs, or a related scientific discipline • 15+ years of pharmaceutical industry experience supporting small-molecule drug development, manufacturing, regulatory affairs, quality, or compliance functions • Experience supporting and implementing regulatory emergency response mechanisms, including Emergency Use Authorization (EUA), expiration dating extensions, and enforcement discretion strategies • Experience with FDA Emerging Technology Program (ETP) engagements and Advanced Manufacturing Technology (AMT) initiatives • Demonstrated experience leading or supporting successful FDA submissions and approvals, including ANDAs, DMFs, NDA supplements, and post-approval changes • Extensive experience interacting directly with FDA and supporting regulatory meetings and inspections • Strong knowledge of FDA drug approval pathways, generic drug regulations, CDER review processes, cGMP requirements, CMC regulatory requirements, Drug Master Files, and Quality Systems • Experience supporting manufacturing operations, technology transfer, validation, and commercial production activities • Ability to assess complex regulatory, manufacturing, and compliance issues and develop practical solutions • Strong written and verbal communication skills • Must be a US Citizen or a Full Green Card holder

🏖️ Benefícios

• Employee-owned company • Approximately 20–25% travel • Equal employment opportunity consideration

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo