Reynolds American Inc. (RAI) Senior Scientist - Regulatory Submissions in Winston Salem, North Carolina
Senior Scientist - Regulatory Submissions
Date:Jan 5, 2020
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 Reynolds American, 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.
Senior Scientist - Regulatory Submissionssupports 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 scientific and operational strategies for current and future smokeless tobacco products.
Principal Duties and Responsibilities:
Lead the development and refinement of tobacco product applications to be submitted to regulatory agencies (i.e., FDA)
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
Contribute expertise in driving primarily Substantial Equivalence (SE) 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 (TPMF)
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)
Provide support for product and process-related regulatory strategies and advocacy efforts, associated regulatory applications, and engagement for new product introductions
Assist the Senior Director of Scientific & Regulatory Affairs in developing, refining, and ultimately driving tactical plans in support of product-related regulatory strategy and objectives
Postgraduate degree in chemistry preferred; 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.
3-5 years of relevant work experience preferred
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 and 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 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 formulate solutions in a complex multi-functional environment
Ability to successfully navigate a 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 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..
Here, you’ll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.
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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