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Sr. Scientist - Regulatory Submissions

Date: Aug 18, 2019

Location: Winston-Salem, NC, US

Company: 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.
 

 

Job Summary:

Senior Scientist - Regulatory Submissions supports enterprise-wide regulatory strategies and advocacy efforts, particularly as they relate to regulatory product clearance by FDA. Through strong leadership and technical expertise, this position supports Scientific & Regulatory Affairs by assisting, developing and/or leading projects and programs aligned with product and process-related scientific and operational strategies for current market products.

 

Principal Duties and Responsibilities:

  • Lead the development and submission of tobacco product pre-market clearance applications to be submitted to regulatory agencies (e.g., FDA)
  • Provide support for product and process-related regulatory strategies and advocacy efforts, associated regulatory applications, and engagement for new product introductions
  • Contribute expertise in driving primarily Substantial Equivalence (Regular) and Exemption from Substantial Equivalence (EXR) submissions, but opportunities will be available to contribute across multiple regulatory pathways, including Pre-Market Tobacco Product Applications (PMTA), Investigational Tobacco Product (ITP) applications, and Tobacco Product Master Files (TPMFs)
  • Establish relationships and partner with both internal and external stakeholders across a broad set of disciplines and contexts (e.g., Law and External Affairs, Product Integrity, Product Development, Consumer Marketing, Product Services, Manufacturing Operations)
  • Develop, refine, and drive tactical plans in support of the strategic overall product-related regulatory strategy and objectives
  • Serve as a technical writer, and contribute scientific and regulatory expertise in leading the development and assembly of regulatory submissions, amendments, and correspondence
  • Prepare data/information to support regulatory submissions, amendments, and correspondence
  • Assist Director of Scientific & Regulatory Affairs in developing, refining, and ultimately driving tactical plans in support of overall product-related regulatory strategy

 

 

Qualifications:

 

Education:

  • Four year degree in chemistry, biological sciences, engineering, or other technical discipline required; other fields (e.g., technical writing or communications) will be considered.
  • Candidates not meeting the specific degree requirements stated above will be considered if they have 7 years of direct experience in tobacco product development and/or preparation of pre-market clearance submissions to regulatory agencies.

 

Experience:

  • 3-5 years of relevant work experience
  • Demonstrated expertise in one or more areas of tobacco-related science or regulatory affairs

 

Required Skills:

  • Demonstrated capacity to quickly accumulate and apply broad, cross-functional business knowledge
  • Ability to conceive, plan and conduct work streams aligned with, and in support of, strategy
  • Strong business and/or technical writing skills and attention to detail
  • Demonstrated ability to manage and execute multiple projects often under heightened time constraints
  • Ability to apply critical thinking & problem-solving skills
  • Demonstrated ability to work both independently and as part of a team
  • Excellent verbal and written communication and presentation skills

 

Preferred Skills:

  • Basic understanding of the tobacco category and FDA regulatory requirements for tobacco products
  • Demonstrated technical writing ability
  • Self-motivated and works with a sense of urgency; orientation to creativity, innovation, and action
  • Ability to anticipate emerging issues and getting results in a complex multi-functional environment
  • Ability to successfully navigate an ambiguous work environment with evolving priorities
  • Demonstrated ability in engaging, influencing, and collaborating with internal and external resources to meet regulatory and business objectives
  • Excellent organizational skills with the ability to manage multiple projects reflecting various timeframes simultaneously
  • Ability to apply and balance strategic and tactical thinking

 

 


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.

Email: TalentAcquisition@RJRT.com


Nearest Major Market: Winston-Salem

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