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Analyst III, Regulatory Process & Compliance

Company: Reynolds
Location: Danbury
Posted on: April 10, 2021

Job Description:

Job Number:-[[id]]

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.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; Modoral Brands, Inc.; R. J. Reynolds Vapor Company; Lorillard Licensing Company, LLC;-Reynolds Brands, Inc.; and Vuse Stores LLC.- This position is with [[custContractualLE]].Here, you'll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day. - Analyst III, Regulatory Process and Compliance/ - - - - S&RA - Regulatory Process and Compliance - - - Job Summary: The Analyst III, Regulatory Process and Compliance, will provide support in the development, maintenance and improvement of the Quality Management System (QMS) / Regulatory Management System (RMS) processes, which may include related application software maintenance and support. The position will maintain documentation and records while assisting with processes, policies, protocols and guidelines for adherence across RAI Operating Companies. -The position will assist in the creation and maintenance of documentation and records, and organize process data for business-relevant reporting.- The position must understand regulatory compliance, process conformance and regulatory-related issues, as well as support of FDA inspections. - Principal Duties and Responsibilities:

  • Assist with initiatives related to creation and maintenance of documentation and records
  • Provide user support for the QMS/RMS software, including use of the application, password assistance and record access support
  • Provision users in compliance with regulatory requirements and information technology policies
  • Perform as hoc data reporting, extraction, assessments, audits and other business initiatives
  • Understand regulatory compliance, process conformance and regulatory related issues
  • Assist with FDA inspections
  • Support the development of compliance assessments - Specific accountabilities may include one or more of the following:
    • Maintain training curriculum and role assignments for Regulatory Process and Compliance. Review and update managers annually, or as changes occur
    • Maintain and track user training to ensure compliance with 21 CFR Part 11 requirements prior to providing user access to relevant system modules
    • Support the execution of change control
    • Execute and provide documented evidence of user acceptance testing for the QMS/RMS software
    • Provide acceptance testing support in the development of computer based training (CBT)
    • Understand deliverables and documents for new validation-relevant and existing validated systems
    • Support regulatory related reporting and processes - - Job Requirements: Education: -
      • BS degree with relevant experience; or
      • Associate degree with relevant experience (3+ years);- or
      • High school diploma or equivalent with relevant experience (5+ years) Experience: -
        • Relevant experience with database structures, web-based applications, or related field
        • Experience working with manufacturing, operations or laboratories preferred Required Skills: -
          • Strong information management or other technical background
          • Strong adherence to process and protocol
          • Ability to prioritize and multi-task to meet timing requirements
          • Strong attention to detail and resolution
          • Good interpersonal skills
          • Team-oriented
          • Effective, accurate oral and written communication skills
          • Ability to understand the relationship between systems, processes and regulations Preferred Skills: -
            • Willingness and ability to achieve and maintain process and regulatory knowledge through job experience and with ongoing courses and seminars
            • Expertise in electronic record archival systems Physical Requirements: -
              • Occasional business travel may be required - LIMITATIONS AND DISCLAIMER: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.- It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.- The Company reserves the right to change or modify job descriptions and employee job duties. Requirements are representative of minimum levels of knowledge, skills and/or abilities.- To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.- Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. ------Compensation/Targeted Bonus
                • Competitive Annual Salary
                • Targeted Annual Bonus
                • Relocation assistance available for those who qualify.Benefit SummaryOur 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; Also Parental leave/Reduced Work Schedule
                  • 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--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 via email

Keywords: Reynolds, Winston-Salem , Analyst III, Regulatory Process & Compliance, Professions , Danbury, North Carolina

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