Regulatory Affairs Principal, Pharmaceutical and Combination Products

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Meridian Bioscience Inc.

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501 - 1000 employés

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

💰 Grant en 2022-01

Biotechnology • Healthcare Insurance • Pharmaceuticals

Meridian Bioscience Inc. est un fabricant de premier plan de réactifs moléculaires et immunologiques destinés aux applications de diagnostic. L'entreprise se spécialise dans la fourniture de solutions innovantes pour améliorer les diagnostics au point de soins et rationaliser le développement de tests pour diverses conditions médicales, y compris les maladies infectieuses et les cancers. Meridian est dédiée à l'avancement du diagnostic médical et à l'amélioration des résultats pour les patients grâce à ses produits et services de haute qualité.

Description

• 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

🎯 Exigences

• 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%

🏖️ Avantages

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