SR. FDDC Regulatory Compliance Clearance Expert
Founded in 1920, 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 2020 revenues of approximately $8.5 billion and is headquartered in Kingsport, Tennessee, USA. For more information, visit www.eastman.com.
Responsibilities
The position of Senior Regulatory Compliance and Clearance Expert will be based out of our Kingsport, TN headquarters.
The role of Senior Regulatory Compliance and Clearance Expert ( Expert ) is to obtain and maintain appropriate regulatory clearances for products used in regulated markets such as direct food additives, cosmetic/personal care (C/PC) formulations, packaging for foods and C/PC products. This expert will work closely with the Product Stewards supporting various business units, global Subject Matter Experts (SMEs), and key internal stakeholders who support the regulatory clearance processes within Product Stewardship & Regulatory Affairs (PS&RA), Legal, and Technology (including Analytical Services). Maintaining market access for existing products and determining the appropriate regulatory requirements for new products is critical to the continued success of Eastman and this Expert will enable this success.
Responsibilities:
Assist/Lead in the submittal of US FDA Food Contact Notification (FCN) dossiers (and similar global government submittals).
Use in-depth knowledge of our current and developing portfolio of products 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.
Work closely with Product Stewards and project teams to outline regulatory requirements, costs, and timelines for new product development.
Execute reviews/approvals for new product commercializations related to applications in regulated end markets
Support creation of testing proposals to facilitate clearances of new products in the relevant regulated markets.
Support the interpretation of analytical, migration, and other relevant testing results in order to prepare new food contact petitions and/or confirm continued compliance of existing products.
Work with Eastman or external legal counsel to petition and defend new product compliance with regulatory authorities.
Provide appropriate information to promote the safe use of our products throughout their entire life-cycle to:
External Stakeholders including customers, distributors, and industry partners.
Internal Stakeholders - including product stewardship and regulatory experts,
manufacturing, technology, product management, and sales & marketing personnel.
Re-evaluate compliance with existing clearances as technology, raw materials, use patterns, and governmental requirements change.
Coordinate projects involving Eastman Legal staff, contracted regulatory consulting companies, and external service providers.
Develop/maintain a sound awareness of global trends in food, food contact, cosmetics, and related regulations.
Participate in advocacy and regulatory compliance initiatives. Represent Eastman in trade associations, subject matter meetings, and other relevant organizations.
Qualifications
Qualifications:
Minimum of a Bachelor of Science degree in chemistry, polymer science, or related science/technical degree required.
5
years of experience in FDA-regulated product submissions/regulations.
2
years experience with US FDA Food Contact Notifications. Other regulatory experience (e.g. TSCA) is a plus.
Other Skills and Abilities:
Attention to detail
Strong communicator, both written and oral
Demonstrated bias for action
Courageous decision making
Results focused
Ability to lead and manage projects
Eastman Chemical Company is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, 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.
Estimated Salary: $20 to $28 per hour based on qualifications.
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