Senior Regulatory Project Manager

Job Description

Job DescriptionDescription:

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

• Research and interpret FDA guidance documents, regulations, and precedents relevant to tobacco and nicotine product applications.
• Analyze scientific, technical, and market data to inform product development and submission strategy.
• Support the preparation of submission documents with accurate data presentation and regulatory alignment.
• Benchmark competitor submissions and regulatory trends to anticipate FDA expectations.

Documentation & Submission Support

• Ensure submission documents meet FDA standards for completeness, accuracy, and scientific rigor.
• Collaborate with technical writers, data managers, and subject matter experts to prepare modules, summaries, and appendices.
• Monitor version control, documentation quality, and timely delivery of supporting data sets.

Stakeholder Engagement

• Serve as a central point of contact between project teams, regulatory consultants, and external partners.
• Facilitate effective communication of project goals, timelines, and responsibilities.
• Support leadership in decision-making through data-driven insights and scenario analyses.

Required Qualifications & Education

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master’s or advanced degree preferred).
• 3+ years of experience in project planning, project management, or regulatory operations within the FDA-regulated space (tobacco/nicotine, pharmaceuticals, medical devices, or food).
• Knowledge of FDA tobacco product pathways (PMTA, MRTP, SE) and regulatory expectations.
• Strong analytical and research skills; ability to interpret scientific data and regulatory guidance.
• Proficiency with project management tools (MS Project, Smartsheet, or similar).
• Exceptional organizational skills, attention to detail, and ability to manage multiple priorities under tight deadlines.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience with tobacco or nicotine product development and testing.
• Familiarity with clinical, behavioral, or toxicological research related to nicotine and tobacco.
• PMP or similar project management certification.
• Prior involvement in FDA application submissions (especially PMTA or MRTP).

Requirements: