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Product Stewardship & Regulatory Affairs Representative

Job Requisition ID:  27861

Eastman is a global specialty materials company that produces a broad range of products found in items people use every day. With the purpose of enhancing the quality of life in a material way, Eastman works with customers to deliver innovative products and solutions while maintaining a commitment to safety and sustainability. The company’s innovation-driven growth model takes advantage of world-class technology platforms, deep customer engagement, and differentiated application development to grow its leading positions in attractive end-markets such as transportation, building and construction, and consumables. As a globally inclusive and diverse company, Eastman employs approximately 14,500 people around the world and serves customers in more than 100 countries. The company had 2018 revenues of approximately $10 billion and is headquartered in Kingsport, Tennessee, USA. For more information, visit www.eastman.com.

Scope:

The role of Product Stewardship & Regulatory Affairs (PSRA) Representative is to obtain and maintain appropriate global regulatory filings for products used in regulated markets such as pharmaceutical ingredients and pharmaceutical packaging. They will work closely with various Quality Assurance teams to obtain and maintain appropriate documents required for these filings. PSRA Representative will also work closely with the Product Stewards supporting various business units, global Subject Matter Experts (SMEs), and key internal stakeholders who support the regulatory registration processes. The PSRA Representative will also have responsibility for arranging and monitoring regulatory intelligence on current and future regulatory actions in conjunction with Product Stewards.  Maintaining market access for existing products and determining the appropriate regulatory requirements for new products is critical to the continued success of Eastman.  PSRA Representative enables this success.  

 

Responsibilities:

 

  • Work closely with Quality Assurance to obtain regulatory documentation required to maintain existing drug master files (DMFs)
  • Prepare and submit annual updates and amendments for DMFs to global regulatory agencies in accordance with the regulatory agencies’ guidelines
  • Track regulatory submissions to ensure timely filings in accordance with regional regulatory requirements
  • Maintain regulatory records, including archiving of regulatory submissions
  • Work closely with Product Stewards and project teams to outline regulatory requirements, costs, and timelines for new DMFs required to support new or expanding products
  • Acquire in-depth knowledge of Eastman’s current and developing portfolio of products used in the regulated markets mentioned above in order to answer compliance related questions from internal partners, external parties, and add value to existing and new customer engagement discussions
  • Maintain awareness of global regulatory legislation and its impact on Eastman products and business
  • Provide appropriate information to promote the safe use of Eastman products throughout their entire life-cycle to:
    • External Stakeholders – including customers, distributors, and industry partners
    • Internal Stakeholders - including Product Stewards and SMEs, manufacturing, technology, product management, and sales & marketing personnel
  • Develop/maintain a sound awareness of global trends in pharmaceutical regulations
  • Assist with special projects related to Product Stewardship & Regulatory Affairs, as needed
  • Assist with regulatory intelligence, as needed
     
     
      

Qualifications:

  • Minimum of Bachelor’s degree (or higher) required
  • 2 – 5+ years of experience in a regulatory affairs role
     

 

Other Skills and Abilities:

  • Attention to detail
  • Strong communicator, both written and oral
  • Proficient in English, both written and oral
  • Strong organizational skills with the ability to prioritize competing demands
  • Demonstrated bias for action
  • Courageous decision making
  • Strong team player who is not afraid to ask for help
  • Results focused
  • Computer skills with proficiency in Microsoft Office and Adobe Acrobat

 

Eastman Chemical Company is an equal opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other characteristics protected by law.

Eastman is committed to creating a powerfully diverse workforce and a broadly inclusive workplace, where everyone can contribute to their fullest potential each day.