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PSRA, FDDC Team Lead

Job Requisition ID:  37975

Responsibilities

The position of Food, Drug. Device, and Cosmetics(FDDC) Team Lead  will be based out of our Kingsport, TN headquarters (although a US-based remote location will be considered).  
 
Scope:
The candidate will work on assignments to ensure Eastman products receive and maintain appropriate clearances for use in highly regulated applications such as food and food packaging, drugs, medical devices and cosmetics (FDDC applications) under the U.S. Food, Drug and Cosmetic Act and similar laws around the world.  In addition, the candidate will have responsibility for managing/leading a team of regulatory experts supporting regulatory clearances in the various FDDC applications and which reports into the Global Product Stewardship and Regulatory Affairs (PSRA) organization.  The successful candidate will work closely with Product Stewardship and Subject Matter Experts in PS&RA.  Outside of PSRA, the candidate should expect to regularly engage key internal stakeholders within Eastman’s business units, Technology, Legal and Analytical Services.  The scope of the role includes the support of existing products, and the development and commercialization of new products in the FDDC application area.  The candidate’s engagement with external stakeholders such as customers, regulatory authorities and industry associations will be of utmost importance in this position.  


Tasks and responsibilities:
 
·    Acquire in-depth product knowledge of our current and developing FDDC application portfolio, in order to answer compliance related questions from internal stakeholders, partners, external parties and engaging new and existing customers in critical discussions.  
·    Create testing proposals to support regulatory clearance for new and existing products in FDDC applications; the primary focus would be for developing test protocols to support clearances for products in contact with food.
·    Interpret analytical results, reports and other technical information regarding the composition and migration of substances into food in order to support existing compliance of our products or to prepare food contact petitions for submission to the US FDA and similar regulatory agencies around the world.
·    When needed, support and defend new clearance dossiers before regulatory authorities.
·    Provide appropriate information to promote the safe use of our products throughout their entire life-cycle to: 
·    Internal Stakeholders - including product stewardship experts, manufacturing, technology, product management and sales and marketing personnel.
·    External Stakeholders – including customers, distributors and industry partners.
·    Evaluate and ensure continued compliance with existing regulatory clearances as technology, raw materials, use patterns and governmental requirements change.
·    Work closely with members of the Eastman Law Department and/or contracted regulatory consulting companies and external service providers.
·    Develop/maintain a sound awareness of global trends in food packaging and related regulations.
·    Participate in advocacy and regulatory compliance initiatives.  Represent Eastman in trade associations and organizations.
·    Manage and implement FDDC team process improvement projects.
·    Provide guidance to direct reports (~4) regarding proper processes and strategy for filing regulatory submissions.
 

Qualifications

Strong candidates for this position should have many of the following skills or be willing to be trained in these areas:
 
·    Education - University Master’s or higher degree or equivalent experience in Polymer Science, Chemistry, Engineering, or related-scientific field.
·    Experience – 3+ years of experience in FDA product stewardship/regulatory compliance expertise.
·    Comprehension and demonstrated application of procedures/processes used for the approval of food contact, drug, medical device and cosmetic applications in the US, EU and around the world.
·    Hands-on product stewardship/compliance experience in clearances for FDDC applications.
·    Ability to work independently and on multiple projects simultaneously.
·    Ability to work effectively in a team and matrix organization together with other regulatory and scientific subject experts, and with business organizations.
·    Be skilled in translating complex scientific topics into comprehensible key messages for different audiences.
·    Ability to engage effectively with authorities, customers, industry groups and other stakeholders.
·    Have strong communication skills, both written and orally.
·    Positive and supportive attitude is a must.
·    Proactive, technically competent, assertive, and ability to successfully perform in high-pressure, global and culturally diverse environments.
·    Ability to make decisions with incomplete data.
·    Travel occasionally, primarily within North America; but, other geographies are a possibility.
·    Speak and write fluent English is mandatory for the position.
 


Nearest Major Market: Asheville
Nearest Secondary Market: Knoxville

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