Master Scientist - Regulatory Submissions

RAI Services Company Winston-Salem, NC

About the Job

Reynolds American Incorporated is positively transforming the tobacco industry. We’re a family of companies that strives for success in everything we do. The future inspires us because our people are igniting the breakthroughs that are redefining the ways adult tobacco consumers enjoy tobacco in the 21st century.

When other companies talk about growth, they only talk about size. At RAI, we focus on the growth of our people. We take pride in each other’s growth and well-being throughout our careers. We invest in your career and total well-being because we know our companies succeed when our people thrive.

At the RAI companies you’ll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.

This position is within Reynolds American Services Company—a subsidiary that provides support services, including compliance, HR, law, finance, information management, and more to all of the subsidiaries of RAI.

 

Reynolds American Incorporated is positively transforming the tobacco industry. We’re a family of companies that strives for success in everything we do. The future inspires us because our people are igniting the breakthroughs that are redefining the ways adult tobacco consumers enjoy tobacco in the 21st century.  When other companies talk about growth, they only talk about size. At RAI, we focus on the growth of our people. We take pride in each other’s growth and well-being throughout our careers. We invest in your career and total well-being because we know our companies succeed when our people thrive. 

At the RAI companies you’ll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.

This position is within Reynolds American Services Company—a subsidiary that provides support services, including compliance, HR, law, finance, information management, and more to all of the subsidiaries of RAI.
 

This Master Scientist role will contribute to enterprise-wide strategies for the development of Premarket Tobacco Product Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs). Through strong leadership and scientific expertise, this role will contribute to Scientific and Regulatory Affairs by providing necessary direction and support to the development of regulatory submissions to support future market product introductions. The role will work collaboratively with the clinical, non-clinical, quality, and product development teams to drive submissions efforts forward in a collaborative setting.

 

Principal Duties and Responsibilities:

  • Lead key work streams critical to the development of Premarket Tobacco Product Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs) for submission to FDA
  • Establish relationships and partner with both internal and external stakeholders across a broad set of disciplines and contexts (e.g. Product Integrity, Product Development, Consumer Marketing, Product Services, Manufacturing Operations, Contract Service Providers, Contract Research Organizations)
  • Contribute to the development of research strategies that support regulatory submissions
  • Develop, refine, and ultimately drive tactical plans to support regulatory submissions and objectives
  • Contribute to and communicate strategic and operational regulatory guidance and expertise to internal stakeholders in a manner consistent with the operating company’s objectives
  • Lead the assembly of PMTAs/MRTPAs and work with stakeholders to ensure the creation, review, and completion of scientific- and product-related documentation is fit for purpose
  • Prepare and revise presentations and documents for interactions with regulatory agencies (e.g., FDA) and other relevant stakeholders (both internal and external)

     

    Job Requirements:

     

    Education:        

    MS or PhD in chemistry, biological sciences, behavioral sciences or other related field 

     

    Experience:       

  • Minimum 3 years of experience or 5 years of progressive relative experience
  • Demonstrated expertise in one or more areas of tobacco-related science, with an emphasis on smokeless tobacco products

     

    Required Skills:

  • Demonstrated experience leading cross-functional teams and driving program execution
  • Ability to conceive, plan and conduct work streams aligned with, and in support of, regulatory strategy
  • Demonstrated ability to manage and execute multiple projects often under heightened time constraints
  • Good influencing skills, project management skills, and ability to work both independently and as part of a team
  • Demonstrated capacity to quickly accumulate and apply broad, cross-functional scientific and business and knowledge
  • Ability to utilize technical principles and theories, ingenuity, and creativity to develop and/or recommend solutions to complex problems
  • Strong scientific and business writing skills and attention to detail
  • Strong ability to apply critical thinking and analytical skills to both known and new information and data
  • Excellent organizational skills, presentation skills, verbal and written communication skills with the ability to interface with executive management and other functions within the company

     

    Preferred Skills:

  • Broad understanding of the tobacco category and relevant industry experience
  • Self-motivated and works with a sense of urgency; orientation to creativity, innovation, and action
  • Ability to successfully navigate an ambiguous work environment with evolving priorities
  • Demonstrated ability to engage, influence, and collaborate with internal and external resources in order to meet regulatory and business objective


Compensation/Targeted Bonus

  • Competitive Annual Salary
  • Targeted Annual Bonus
  • Relocation assistance available for those who qualify.

 

Benefit Summary

Our company offers very competitive compensation and benefit plans, including:

  • 401(k) plan that offers opportunity to save on pre- and post-tax basis up to 50 percent of eligible compensation. Company matches 100 percent of employee pre-tax/Roth (401k) contributions up to six percent
  • Comprehensive health- and welfare-benefits package
  • Eleven paid company holidays annually, plus a generous paid vacation plan based on length of service
  • Company-paid sick and personal days, funeral leave and jury duty leave
  • Confidential personal financial counseling service
  • On-site health clinics and fitness centers
  • A matching grants program that enables employees to direct and double their donations to qualifying charitable organizations of their choice
  • Health-care advocacy service
  • Volunteer service opportunities
  • Federal credit union membership through Allegacy Federal Credit Union
  • Extensive training opportunities  

ABOUT OUR ORGANIZATION:

Reynolds American Inc. is an indirect, wholly owned subsidiary of British American Tobacco p.l.c., and the U.S. parent company of R. J. Reynolds Tobacco Company; Santa Fe Natural Tobacco Company, Inc.; American Snuff Company, LLC; Niconovum USA, Inc.; Niconovum AB; R. J. Reynolds Vapor Company; Lorillard Licensing Company, LLC; and Reynolds Brands, Inc..


Reynolds American Inc. and its affiliated companies is an Equal Opportunity / Affirmative Action Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Our organization offers a level of challenge, responsibility and creativity for motivated employees that stands apart from the crowd.

We are also committed to employing a diverse workforce and valuing different perspectives, experiences and talents to maximize the company's potential for successfully achieving its business objectives.

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Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.

Telephone: 262-439-1893

Email: TalentAcquisition@RJRT.com