Regulatory Affairs Principal, Pharmaceutical and Combination Products

🕒 May 8

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Meridian Bioscience Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Grant on 2022-01

Biotechnology • Healthcare Insurance • Pharmaceuticals

Meridian Bioscience Inc. is a leading manufacturer of molecular and immunological reagents designed for diagnostic applications. The company specializes in providing innovative solutions to enhance point-of-care diagnostics and streamline assay development for various medical conditions, including infectious diseases and cancers. Meridian is dedicated to advancing medical diagnostics and improving patient outcomes through its high-quality products and services.

📋 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

🎯 Requirements

• 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%

🏖️ Benefits

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