Director, Regulatory Affairs – Fractional

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $300 - $350 / hour

⏰ Full Time

🔴 Lead

🚔 Compliance

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Lexitas

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🛡️ Insurance

💼 Consulting

📦 Logistics

💰 Debt Financing on 2016-09

Insurance • Consulting • Logistics

Lexitas is a trusted provider of legal and corporate support services, offering a wide range of services such as court reporting, record retrieval, legal talent outsourcing, registered agent services, process service, investigations, and eLaw case tracking. The company addresses the needs of legal, insurance, and corporate leaders by delivering responsive professional services combined with advanced technology solutions. Lexitas is dedicated to accuracy, timeliness, and reliability, making it an ideal partner for law firms, insurance companies, and corporations seeking to enhance efficiency and reduce costs in their legal and administrative operations.

📋 Description

• Bring both strategic leadership and hands-on execution experience across the FDA regulatory landscape • Navigate regulatory pathways and interactions across all three FDA medical product centers: CDER, CBER, CDRH

🎯 Requirements

• Extensive ophthalmology regulatory experience • Proven FDA submission and agency interaction expertise • Ability to develop regulatory strategy while driving tactical execution • Experience supporting product development from early-stage through commercialization • Strong cross-functional collaboration and leadership skills • International regulatory affairs experience supporting product development and commercialization outside the U.S. (highly desirable) • Familiarity with regulatory frameworks and health authority interactions in Europe/UK, Latin America, Japan, Australia, and broader APAC markets, including China (highly desirable) • Experience developing global regulatory strategies and coordinating submissions across multiple jurisdictions (highly desirable)