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Master Scientist - Regulatory Submissions

Company: R. J. Reynolds Tobacco Company
Location: Winston Salem
Posted on: June 10, 2019

Job Description:

Date: May 23, 2019Location: Winston-Salem, NC, USCompany: RAIReynolds 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 - Regulatory Submissions 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 critical to the development, submission, and management of tobacco product pre-market clearance applications* Contribute expertise in driving primarily Pre-Market Tobacco Product Applications (PMTAs), but opportunities will be available to lead and/or contribute across multiple regulatory pathways, including Substantial Equivalence (SE) submissions (Provisional & Regular), Exemption from Substantial Equivalence (EXR) submissions, 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, Contract Service Providers, Contract Research Organizations)* Develop, refine, and drive tactical plans in support of the strategic overall product-related regulatory strategy and objectives* Serve as a primary technical writer, and contribute scientific and regulatory expertise in leading the development and assembly of regulatory submissions, amendments, and correspondence* Drive projects to support regulatory submissions and strategic objectives through leadership of cross-functional teams* Partner with Sr. Director of Scientific & Regulatory Affairs in developing and refining strategic approaches to regulatory submissionsQualifications:Education:* Graduate degree (MS or Ph.D.) in chemistry, biological sciences, toxicology, physics, engineering or other technical discipline preferred; 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.Certifications:* Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certification (RAC) preferred, but not required.Experience:* Minimum 3 years of experience or 5 years of progressive relative experience* Demonstrated expertise in one or more areas of tobacco-related science or regulatory affairsRequired 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 skillsPreferred Skills:* 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 thinkingCompensation/Targeted Bonus* Competitive Annual Salary* Targeted Annual Bonus* Relocation assistance available for those who qualify.Benefit SummaryOur 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 opportunitiesABOUT 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.Email: TalentAcquisition@RJRT.comNearest Major Market: Winston-Salem

Keywords: R. J. Reynolds Tobacco Company, Winston-Salem , Master Scientist - Regulatory Submissions, Other , Winston Salem, North Carolina

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