Regulatory Affairs Principal, Pharmaceutical and Combination Products

About Meridian

Meridian Bioscience is a fully integrated life science company developing and delivering innovative diagnostic and life science solutions that improve patient outcomes worldwide. Our work spans discovery to diagnosis, and we are expanding into combination drug-device products that redefine how diseases are detected and managed.

We are seeking a Regulatory Affairs Principal to play a key role in advancing our pipeline, including the BreathID platform—a unique combination product at the intersection of pharmaceuticals and diagnostics.

Job Summary

The Regulatory Affairs Principal will provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products. This individual will 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.This is a high-impact role for a regulatory professional who thrives in a collaborative environment and wants to shape regulatory strategy for innovative combination products.

Key Duties

Lead and contribute to regulatory strategy for pharmaceutical and combination products across development and lifecycle stages

Author and review INDs, NDAs, supplements, and other global regulatory submissions

Serve as a primary interface with FDA CDER, including leading preparation for and participation in agency meetings (e.g., Type B/C)

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

Qualifications

Experience

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

Education

Bachelor’s degree in a scientific discipline required

Advanced degree (MS, PhD, PharmD) preferred

Certifications

RAC (US or Drugs) preferred

Travel

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