Sr Scientist - Scientific & Reg. Affairs Provisional-Submissions
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.
This Senior / Sr. Staff Scientist role supports enterprise-wide regulatory strategies and advocacy efforts, particularly as they relate to regulatory clearance of provisional combustible tobacco products by FDA. Through strong leadership and technical expertise, this role supports Scientific & Regulatory Affairs by assisting, developing and/or leading projects and scientific programs aligned with product and process-related strategies for current market products.
Principal Duties and Responsibilities:
Lead the development (or assist in the development of components) of pre-market clearance applications [e.g., Provisional Substantial Equivalence (SE) submissions] for tobacco products under review by regulatory agencies (e.g., FDA)
Provide support for product and process-related regulatory strategies and advocacy efforts, associated regulatory applications, and engagement for provisional tobacco products
Contribute regulatory expertise to the development of robust provisional SE submissions and amendments
Function as a regulatory partner with R&D and the Provisional Combustible Submissions & Engagement group to develop S&RA strategy relating to appropriate data for inclusion in submissions and amendments
Partner with stakeholders in R&D to develop responses, scrutinize internally-provided information, identify potential areas for further discussion, and develop tactical plans to address gaps
Provide chemistry-related support associated with regulatory applications
Utilize technical principles and theories, ingenuity, and creativity to assist, develop, and/or recommend solutions to complex problems
Develop, refine, and advance company positions on various issues (e.g., product-related, manufacturing processes, etc.) within the context of regulatory submissions
Partner/collaborate with various stakeholder groups (e.g., Product Development, Consumer Marketing, Product Services, and Manufacturing Operations)
Assist Director of Scientific & Regulatory Affairs in developing, refining, and ultimately driving tactical plans in support of the strategic overall product-related regulatory strategy and objectives
Assist Director of Scientific & Regulatory Affairs in providing strategic and operational regulatory guidance and expertise to internal stakeholders in a manner consistent with operating company’s objectives and interests
Coordinate and participate in preparation and revision of presentations and documents for interactions with regulatory agencies (e.g., FDA) and other relevant external stakeholders
Four year degree required - preferred disciplines include technical writing & communication, science (i.e., chemistry, physics, engineering), or other technical discipline, plus a minimum of 3-5 years of relevant experience.
Candidates not meeting the above degree requirements 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.
Job level commensurate with educational background & work experience.
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
Basic understanding of the tobacco category
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 in order to meet regulatory and business objectives
Excellent organizational & project management skills with the ability to manage multiple projects reflecting various timeframes simultaneously
Ability to apply and balance strategic and tactical thinking
Basic understanding of analytical chemistry methodology
Knowledge of cigarette design features (e.g., tobacco blends, materials) and their impact on cigarette smoke composition
- 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.
Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.