Are you looking for an exciting job opportunity? Look no further! McKinney RSA is now hiring a talented individual to fill the role of Regulatory Submissions Project Manager.


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.   

If interested, please submit your application here: Apply

Position Summary:

The Regulatory Submissions Project Manager will be responsible for helping to build strong client relationships. This role provides clients with the appropriate level of service and ensures clients know what to expect from the regulatory team. The Project Manager will have a proven track record of successful project management, and a deep knowledge of methods and regulatory drivers. The Regulatory Submissions Project Manager will report to the CEO.    


  • Review project’s requirements (permits, scope of work, compound list, reporting format, regulatory limits, etc.) and ensure that results meet project’s requirements
  • Review, streamline and develop/update departmental processes and work instructions to ensure a high-level client experience, consistency and maximize team efficiencies, while maintaining a focus on quality, innovation and continuous improvement
  • Develop and manage project plans and timelines
  • Transmit project schedules, technical and turn-around requirements accurately to the analytical groups, and obtain their commitment to meet the requirements  
  • Manage resources effectively to ensure all projects are appropriately prioritized and key goals are met on time
  • Act as the primary regulatory representative on multi-disciplinary project teams and provide strategic regulatory guidance on development plans
  • Ensure effective and timely execution of regulatory filings in compliance with relevant regulatory standards and commitments
  • Assist in the planning and preparation of content for submissions to Regulatory Agencies and coordinate responses to Regulatory Agency requests
  • Prepare meeting requests and briefing documents; ensure team is ready for meetings and teleconferences with Regulatory Agencies
  • Develop and maintain knowledge of US regulations as appropriate for the assigned program(s)
  • Keep cross-functional team members apprised of new regulations, standards, policies, and guidelines issued by Regulatory Agencies that may impact the company
  • Engage cross-functional stakeholders to align on and achieve company and program objectives
  • Assist in contributing to the development and maintenance of departmental processes, policies, SOPs and associated documents
  • Participate in initiatives aimed at improving internal standards and systems

Required Skills/Abilities:

  • Excellent verbal and written communication skills
  • Excellent organizational skills and attention to detail
  • Time management skills with a proven ability to meet deadlines
  • Able to maintain a high level of integrity and discretion in handling confidential information
  • Ability to function well in a high-paced and, at times, stressful environment
  • Self-starter with the ability to take initiative
  • Strong ability to execute work with a diversity, equity, and inclusion lens
  • Extremely proficient with Microsoft Office Suite or similar software with the ability to learn new or updated software; experience with Wrike or similar project management software is preferred

Education and Experience:

  • Bachelor’s degree in science, health or business
  • Proven experience in project management with 3-5 years in a similar role
  • Project Management Professional Certification preferred
  • Knowledge of general regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations
  • Knowledge of US laws, regulations, and guidance for consumer products, tobacco/nicotine products preferred

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.