Senior Level Food Contact Regulatory Affairs ExpertWe are seeking a senior level Food Contact Regulatory Affairs subject matter expert to join our Americas Product Stewardship team. This role will provide independent technical and regulatory expertise for U.S. FDA food contact and indirect food additive requirements with an additional focus on MERCOSUR food contact regulations. The role provides regulatory leadership and technical expertise to support the development, manufacture, and commercialization of products used in food contact applications. The successful candidate will proactively and independently monitor and interpret evolving regulatory requirements, assess product and raw material compositions to determine product compliance, and manage food contact regulatory portfolios across Celanese's business lines. This position is responsible for ensuring that food contact compliance is established, maintained, and continuously evaluated in line with regulatory developments and business needs. The role will provide strategic regulatory guidance to internal cross-functional stakeholders, enabling business growth while ensuring compliance with applicable food contact legislation and customer requirements. The preferred location is at one of our facilities in Florence, Kentucky or Irving, Texas or Wilmington, Delaware.
Responsibilities:
This is a senior individual contributor role expected to operate with a high degree of independence. The role is accountable for making technical regulatory assessments, documenting defensible compliance determinations, advising business and technical stakeholders on risk-based options, and escalating high-risk or novel questions to Legal, Toxicology, Quality, or Product Stewardship leadership as appropriate.
Key Responsibilities:- Serve as the Sr. Product Stewardship SME for food contact regulations, with primary focus on:
- U.S. FDA food contact regulations applicable to polymeric materials and additives, including relevant provisions under 21 CFR.Food Contact Notifications (FCNs), Food Additive Regulations, and Threshold of Regulation (TOR) exemptions.
- MERCOSUR food contact regulations for plastic materials and articles, including applicable positive lists and related compliance requirements.
- Monitor, evaluate, and communicate emerging regulatory developments, legislative changes, and enforcement trends impacting food contact applications.
- Independently assess raw materials, additives, formulations, and finished products for compliance with applicable food contact requirements.
- Maintain and manage the food contact product portfolio, ensuring regulatory assessments and compliance determinations remain current and aligned with evolving legislation.
- Conduct product risk assessments and risk management activities in close collaboration with toxicologists to evaluate substance status, migration considerations, and food contact compliance.
- Lead the assessment of complex food contact compliance questions, providing regulatory expertise to support customer requirements, business decisions, and commercialization activities.
- Define and oversee external testing strategies, including collaboration with accredited laboratories and test institutes, as needed to support food contact compliance assessments.
- Partner with manufacturing, quality, procurement, legal, and technology teams to ensure compliance throughout the product lifecycle.
- Contribute to the continuous improvement of product stewardship processes, regulatory databases, and compliance management systems.
- Develop and provide food contact regulatory guidance, knowledge-sharing, and training initiatives for internal stakeholders.
Qualifications:
Bachelor's degree in Chemistry, Polymer Science, Chemical Engineering, Toxicology, Regulatory Affairs, Food Science, or a related scientific discipline required; advanced degree preferred.8+ years of experience in Product Stewardship, Regulatory Affairs, Product Safety, Food Contact Compliance, or a related technical regulatory role. Demonstrated experience interpreting and applying U.S. FDA and/or MERCOSUR food contact regulations, particularly for chemicals, polymers, additives, compounds, or specialty materials. Strong understanding of food contact compliance assessments, migration principles, substance authorization frameworks, and regulatory risk evaluation. Experience working with cross-functional business and technical teams in a global environment. Familiarity with SAP EHS, Product Compliance systems, and regulatory databases. Strong interpersonal, communication, and stakeholder management skills. Excellent analytical thinking, problem-solving, organization, and risk assessment capabilities. Ability to independently interpret regulations, apply them to product compositions and use conditions, document conclusions, and provide pragmatic, risk-based recommendations that balance business objectives with compliance obligations.
Preferred Qualifications:
Experience with additional global food contact regulatory frameworks, including European Union, China, and Japan food contact regulations.
Experience supporting food contact compliance for polymers, compounds, and related materials, including substance assessments, compliance determinations, and portfolio management.
Spanish or Portuguese reading capability, or demonstrated experience working with translated regulatory texts and local counsel or consultants.
