Key Facts

Remote From:

United States

Category: Regulatory Affairs Manager

Full time

Senior (5-10 years)

English

Hard Skills

FDA Regulations Combination Products Regulatory Compliance Pre-Clinical Development

Other Skills

•
Collaboration
•
Mentorship
•
Communication

Roles & Responsibilities

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

Requirements:

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
Develop and deliver high-quality briefing documents, responses, and regulatory communications

Job description

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