Sr Scientist S&RA FMC Submissions

Company: British American Tobacco
Location: Colfax
Posted on: January 9, 2022

Job Description:

Reynolds American is evolving at pace - truly like no other organization. To achieve the ambition, we have set for ourselves, we are looking for colleagues who are ready to live our ethos every day. Come be a part of this journey!WE ARE LOOKING FOR A Sr Scientist - Scientific & Reg AffairsSENIORITY LEVEL: Junior LevelFUNCTION: Scientific Research & DevelopmentLOCATION: Winston-Salem, NC-- --- -ROLE POSITIONING AND OBJECTIVES-- -Reports toSr Manager S&RA FMC SubmissionsNumber of Direct Reports N/ACore RelationshipsInternal External Geographic Scope-- - LocalTravel RequiredN/A-- -WHAT YOU WILL BE ACCOUNTABLE FORLead the development and submission of tobacco product pre-market clearance applications to be submitted to regulatory agencies (e.g., FDA)Provide support for product and process-related regulatory strategies and advocacy efforts, associated regulatory applications, and engagement for new product introductionsContribute expertise in driving primarily Substantial Equivalence (Regular) and Exemption from Substantial Equivalence (EXR) submissions, but opportunities may be available to contribute across multiple regulatory pathways, including Pre-Market Tobacco Product Applications (PMTA) 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., legal, compliance, product development, marketing, operations)Develop, refine, and drive tactical plans in support of the strategic overall product-related regulatory strategy and objectivesServe as a technical writer, and contribute scientific and regulatory expertise in leading the development and assembly of regulatory submissions, amendments, and correspondencePrepare data/information to support regulatory submissions, amendments, and correspondenceAssist Senior Manager of Scientific & Regulatory Affairs in developing, refining, and ultimately driving tactical plans in support of overall product-related regulatory strategyCAN THIS BE YOUR FUTURE ROLE? Are you familiar with FDA regulatory requirements for tobacco products in the United States?What is your idea of a fulfilling work environment?-- -ESSENTIAL EXPERIENCE, SKILLS AND KNOWLEDGE3-5 years of relevant work experienceDemonstrated expertise in one or more areas of tobacco-related science or regulatory affairsDemonstrated capacity to quickly accumulate and apply broad, cross-functional business knowledgeStrong business and/or technical writing skills and attention to detailDemonstrated ability to manage and execute multiple projects often under heightened time constraintsDemonstrated ability to work both independently and as part of a teamFour year degree in chemistry, biological sciences, engineering, or other technical discipline; other fields (e.g., technical writing or communications) will also be considered.Candidates not meeting the above degree requirements 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.BENEFICIAL Ability to conceive, plan and conduct work streams aligned with, and in support of, strategyDemonstrated ability in engaging, influencing, and collaborating with internal and external resources to meet regulatory and business objectives-- --- --- -WE ARE REYNOLDS AMERICAN"-- - -A member of the BRITISH AMERICAN TOBACCO GROUPAt Reynolds American, we are committed to our Purpose of creating A Better Tomorrow. This is what drives our people and our passion for innovation. See what is possible for you at REYNOLDS AMERICAN.Global Top Employer with 53,000 British American Tobacco employees across more than 180 marketsReynolds American certified as Great Place to Work Brands sold in over 200 markets, made in 44 factories in 42 countriesNewly established Tech Hubs building world-class capabilities for innovation in 4 strategic locations Diversity leader in the Financial Times and International Women's Day Best Practice winnerSeal Award winner - one of 50 most sustainable companies BELONGING, ACHIEVING, TOGETHERHave you been on a career break for 18 months or longer? Are you ready to return to your career? If your answers to these questions is yes, we would love to hear from you. Regardless of why you took a break, we value you for all the skills you can bring to the workforce. Reignite your career, work flexibly, be part of a dynamic team and upskill yourself with on-the-job training and development support.Collaboration, diversity and teamwork underpin everything we do here at Reynolds American. We know that collaborating with colleagues from different backgrounds is what makes us stronger and best prepared to meet our business goals. Come bring your difference!

Keywords: British American Tobacco, High Point , Sr Scientist S&RA FMC Submissions, Other , Colfax, North Carolina