Regulatory Affairs Principal, Pharmaceutical and Combination Products

🕒 Maio 8

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Meridian Bioscience Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 Grant em 2022-01

Biotechnology • Healthcare Insurance • Pharmaceuticals

Meridian Bioscience Inc. é um fabricante líder de reagentes moleculares e imunológicos projetados para aplicações diagnósticas. A empresa é especializada em fornecer soluções inovadoras para aprimorar os diagnósticos no ponto de atendimento e otimizar o desenvolvimento de ensaios para várias condições médicas, incluindo doenças infecciosas e cânceres. A Meridian é dedicada ao avanço dos diagnósticos médicos e à melhoria dos resultados dos pacientes por meio de seus produtos e serviços de alta qualidade.

Descrição

• Provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products • Serve as a key regulatory partner to cross-functional teams, with a primary focus on FDA CDER interactions, IND/NDA submissions, and global regulatory strategy • Author and review INDs, NDAs, supplements, and other global regulatory submissions • Develop and deliver high-quality briefing documents, responses, and regulatory communications • Provide regulatory guidance on clinical, nonclinical, and CMC development activities • Drive combination product regulatory strategy, including coordination with FDA’s Office of Combination Products (OCP) • Advise on labeling strategy, including prescribing information and device components of combination products • Assess regulatory impact of development and post-approval changes and define appropriate regulatory pathways • Support global regulatory activities, including submissions and interactions with ex-U.S. health authorities (e.g., EMA) • Stay current on evolving regulatory requirements and translate them into actionable guidance for teams • Mentor and provide guidance to junior regulatory team members

🎯 Requisitos

• 7+ years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products • Proven experience with FDA CDER submissions, including INDs, NDAs, and/or supplements • Demonstrated success interacting with FDA, including meeting preparation and regulatory strategy execution • Experience with combination products (drug-device) strongly preferred • Working knowledge of U.S. regulatory requirements (21 CFR 210/211, Part 4) and relevant FDA guidance • Exposure to global regulatory environments (e.g., EMA, ICH) preferred • Bachelor's degree in a scientific discipline required • Advanced degree (MS, PhD, PharmD) preferred • Certification RAC (US or Drugs) preferred • Travel 0-10%

🏖️ Benefícios

• Competitive salary • Flexible working hours • Professional development budget • Home office setup allowance • Global team events