Senior Regulatory Project Manager

Job Description

Job Description

Description : The Opportunity :

Join a team that is passionate about guiding companies of all sizes successfully through every step of a complex regulatory process. McKinney Regulatory Science Advisors helps clients thrive in a regulated environment by providing regulatory, scientific and stakeholder engagement leadership.

We are a virtual company and this position is fully remote (work from home). We offer competitive pay and a comprehensive benefit package, including medical, dental, vision and 401k.

To learn more, please visit our company website : https : / / mckinneyrsa.com /

Position Summary

We are seeking a highly organized and detail-oriented Senior Regulatory Project Manager to lead planning, scheduling, and coordination for regulatory submissions related to tobacco and nicotine products under the U.S. Food and Drug Administration (FDA). The Project Planner will support cross-functional teams in preparing, compiling, and submitting complex applications (e.g., PMTA, SE, MRTP) by ensuring timelines, resources, and deliverables align with FDA requirements. This role requires a blend of project management expertise, regulatory awareness, and analytical research skills to evaluate product data and ensure high-quality submissions.

Duties / Responsibilities

Project Planning & Coordination

• Develop and maintain detailed project plans, timelines, and deliverables for FDA submissions.
• Coordinate cross-functional teams including regulatory affairs, R&D, clinical, toxicology, quality, and legal.
• Identify potential risks, bottlenecks, and compliance gaps; implement mitigation strategies.
• Track progress and provide regular status updates to leadership and stakeholders.

Regulatory Research & Analysis

Documentation & Submission Support

Stakeholder Engagement

Required Qualifications & Education

Preferred Qualifications

Requirements :