Reynolds American Inc. (RAI) Regulatory Document Specialist in Winston-Salem, North Carolina
Regulatory Document Specialist
Date:Apr 18, 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.
Job Title: Regulatory Document Specialist
This Regulatory Document Specialist will support enterprise-wide regulatory strategies and advocacy efforts, particularly as they relate to regulatory submissions for new products. This role supports Scientific & Regulatory Affairs by supporting the electronic submissions team to produce applications aligned with strategies for future market introductions. Specifically, the Regulatory Document Specialist will support electronic submission application projects by ensuring the accuracy and compliance of highly-detailed Regulatory documentation for future electronic product submissions (e-submissions).
POSITION DUTIES AND RESPONSIBILITIES
Support the development of components (i.e., documents) for product applications (e.g., Pre-Market Tobacco Product Applications and Modified Risk Tobacco Product Applications) to be electronically submitted to regulatory agencies (e.g., FDA)
Comply and ensure compliance of FDA review standards for documents in preparation for regulatory submissions
Review and prepare documents in accordance with regulatory agency guidelines for e-submission readiness, including:
Formatting Microsoft Word documents using content templates or MS Word styles consistently to prepare for electronic submission publishing.
Performing document reviews, create hyperlinks/cross-references/bookmarks, as required.
Maintain various types of submission files through version tracking, database management, file naming, etc.
Initiate and support continuous process improvement related to the delivery of regulatory services
Assist Sr. Manager and eSubmissions team of Scientific & Regulatory Affairs in providing strategic and operational guidance, regulatory support and technical expertise to internal stakeholders in a manner consistent with the company’s objectives
Maintain awareness of relevant federal guidance, in particular with electronic submissions
- High School Diploma or GED equivalency is required, however, a Bachelor's degree in Library Science, Communications, English, or Technical Writing is preferred.
Job level commensurate with educational background & work experience.
A minimum of 3-5 years of experience with Regulatory submission document preparation and/or electronic submissions required.
Tobacco industry experience, preferred.
Ability to recognize documents that are not compliant for electronic submissions
High competency with MS Office and Adobe Acrobat
Technical knowledge of US regulatory requirements for electronic submissions
Demonstrated capacity to quickly accumulate and apply broad, cross-functional business knowledge
Demonstrated ability to manage and execute multiple projects often under heightened time constraints
Strong attention to detail, organizational skills, and computer/IT skills
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 skills
Demonstrated ability to engage, influence, and collaborate with internal resources in order to meet regulatory and business objectives
Direct experience with preparing documents and reviewing the publishing of documents
Ability to anticipate emerging issues and obtain results in a complex multi-functional environment
Ability to successfully navigate an ambiguous work environment with evolving priorities
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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