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Regulatory Document Specialist

Date: Mar 20, 2019

Location: Winston-Salem, NC, US

Company: RAI

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

     

    JOB REQUIREMENTS

     

    EDUCATION

  • 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.

     

    EXPERIENCE

    A minimum of 3-5 years of experience with Regulatory submission document preparation and/or electronic submissions required.

    Tobacco industry experience, preferred.

     

    REQUIRED SKILLS

  • 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

     

    PREFERRED 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

     

     

 

 

 

 


Compensation/Targeted Bonus

  • Competitive Annual Salary
  • Targeted Annual Bonus
  • Relocation assistance available for those who qualify.

 

Benefit Summary

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.

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Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.

Email: TalentAcquisition@RJRT.com


Nearest Major Market: Winston-Salem

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