Reynolds American Inc. (RAI) Master Scientist - Regulatory Submissions in Winston-Salem, North Carolina
Master Scientist - Regulatory Submissions
Date:Jul 17, 2019
Location:Winston-Salem, NC, US
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 regulatory strategies and advocacy efforts, particularly as they relate to regulatory clearance of tobacco products by FDA. Through strong leadership and technical expertise, this role will contribute to Scientific & Regulatory Affairs by providing necessary leadership, direction, and support to the development of regulatory submissions and associated amendments in support of product commercialization.
Principal Duties and Responsibilities:
Lead key work streams and cross-functional working groups critical to the development, submission, and management of Substantial Equivalence (SE) applications in support of new combustible tobacco product introductions
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, and ad hoc service providers)
Partner with Director of Scientific & Regulatory Affairs in developing and refining strategic approaches to regulatory submissions
Develop, refine, and drive tactical plans in support of the strategic overall product-related regulatory strategy and objectives; ensure tactical alignment within and across regulatory submissions
Serve as a primary technical writer as part of submission development
Contribute scientific and regulatory expertise in leading the development and assembly of regulatory submissions, amendments, and correspondence
When necessary, drive secondary projects to support regulatory submissions and strategic objectives through leadership of cross-functional teams
Utilize technical principles and theories to assist, develop, and/or recommend solutions to complex problems
Drive projects to support generation of data/results, analyze and interpret data/results to meet technical objectives to support regulatory submissions
Graduate degree (MS or Ph.D.) in chemistry, biological sciences, toxicology, physics, engineering or other technical discipline; other fields (e.g., technical writing or communications) will also be considered.
Candidates with BS/BA degrees in the above will also be considered but must have strong record of relevant experience and high performance.
3-5 years of relevant work experience
Demonstrated expertise in one or more areas of tobacco-related science or regulatory affairs
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
Strong understanding of tobacco category and FDA regulatory requirements for tobacco products
Ability to work and make decisions with minimal supervision
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
Competitive Annual Salary
Targeted Annual Bonus
Relocation assistance available for those who qualify.
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.
Onlyapplicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.
Nearest Major Market:Winston-Salem
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