Description
About McKinney Regulatory Science Advisors
McKinney Regulatory Science Advisors (MRSA) helps clients thrive in a regulated environment by providing regulatory, scientific and stakeholder engagement leadership. We are passionate about guiding companies of all sizes successfully through every step of a complex regulatory process.
McKinney Regulatory Science Advisors, we’re not just shaping the future of nicotine product testing — we’re building a workplace where talented professionals thrive. We offer competitive compensation and a comprehensive benefits package that includes medical, dental and vision.
To learn more, please visit our company website: https://mckinneyrsa.com/
Position Overview
The Regulatory Project Manager is responsible for leading and coordinating regulatory strategies and submissions for tobacco and nicotine products. This role ensures compliance with evolving regulatory requirements while driving cross-functional execution of complex regulatory projects, including internal and external resources and strategy continuity.
Essential Duties And Responsibilities
Regulatory Strategy & Execution
Application Process
McKinney Regulatory Science Advisors is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. McKinney Regulatory Science Advisors does not discriminate in hiring or employment practices based on race, color, religion, gender, age, sexual orientation, marital or familial status, national origin, non-job-related disability, or status as a veteran.
If you are looking to make an impact in a dynamic and visionary company, we invite you to apply for this opportunity at McKinney Regulatory Science Advisors.
About McKinney Regulatory Science Advisors
McKinney Regulatory Science Advisors (MRSA) helps clients thrive in a regulated environment by providing regulatory, scientific and stakeholder engagement leadership. We are passionate about guiding companies of all sizes successfully through every step of a complex regulatory process.
McKinney Regulatory Science Advisors, we’re not just shaping the future of nicotine product testing — we’re building a workplace where talented professionals thrive. We offer competitive compensation and a comprehensive benefits package that includes medical, dental and vision.
To learn more, please visit our company website: https://mckinneyrsa.com/
Position Overview
The Regulatory Project Manager is responsible for leading and coordinating regulatory strategies and submissions for tobacco and nicotine products. This role ensures compliance with evolving regulatory requirements while driving cross-functional execution of complex regulatory projects, including internal and external resources and strategy continuity.
Essential Duties And Responsibilities
Regulatory Strategy & Execution
- Lead development and execution of regulatory strategies for new and existing tobacco/nicotine products.
- Manage submissions such as PMTAs, SE Reports, MRTP applications, TPD notifications, and other global filings.
- Interpret regulatory requirements and translate them into actionable project plans.
- Serve as the primary project manager for regulatory initiatives, ensuring timelines, budgets, and deliverables are met.
- Coordinate cross-functional teams including toxicology, clinical, quality, and marketing.
- Develop and maintain detailed project plans, risk registers, and status reports.
- Ensure verbiage and format of all documents adhere to current FDA guidance.
- Support preparation for meetings, responses to deficiency letters, and information packages for FDA review.
- Bachelor’s degree in Life Sciences, Regulatory Affairs, Public Health, Chemistry, or related field required
- 3-5 years of regulatory affairs experience, preferably in tobacco, nicotine, pharmaceuticals, or highly regulated consumer products
- Demonstrated experience with FDA CTP submissions (PMTA, SE, MRTP strongly preferred)
- Proven track record managing complex, cross-functional regulatory projects
- Strong project management skills (PMP or equivalent preferred)
- Excellent written and verbal communication skills
- Ability to manage multiple priorities in a fast-paced, evolving regulatory environment
- Strong analytical and problem-solving abilities
Application Process
McKinney Regulatory Science Advisors is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. McKinney Regulatory Science Advisors does not discriminate in hiring or employment practices based on race, color, religion, gender, age, sexual orientation, marital or familial status, national origin, non-job-related disability, or status as a veteran.
If you are looking to make an impact in a dynamic and visionary company, we invite you to apply for this opportunity at McKinney Regulatory Science Advisors.