Kraton Corporation · 2 weeks ago
Senior Specialist, Product Regulatory
Spring, TX
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expKraton Corporation is looking for a Senior Specialist in Product Regulatory to join their team at the Global Headquarters in The Woodlands, Texas. The role involves ensuring compliance of Kraton Polymers’ product portfolio with regulatory and industry standards, collaborating with internal stakeholders, and driving technical direction in regulatory matters.
ChemicalElectronicsMedical
Responsibilities
Act as subject matter expert for sensitive applications in the following Polymers intermediates markets:
Investigate and respond to complex customer requests for regulatory information in support of sensitive applications. Collaborate with other stakeholders as needed
Maintain a thorough understanding of the regulations in regions and business applications as assigned. Monitor evolving regulations and standards and assess their impact on Kraton’s portfolio. Lead the development of compliance strategies and required submissions
Assist in the development and launch of new products for relevant business applications; defining regulatory requirements and assisting in development and implementation of plans to bring the products to market in a timely and cost-effective manner
Maintain a thorough understanding of the strategic goals for global expansion and commercialization and be able to execute on plan. Manage Polymers Product Regulatory Bulletins and database integrity pertaining to global regulations and standards
Plan and lead periodic audits of facilities, plants and warehouses in line with Good Manufacturing Practices (GMP) and internal compliance systems
As a regulatory point of contact for US facilities, develop and conduct training related to product regulatory requirements for internal and external stakeholders
Represent Kraton in assigned trade organizations (may hold leadership position) or at conferences
Drive technical direction to advocate for regulatory requirements in line with the company's interests
Work with management systems and workflows to review raw materials and finished goods for regulatory compliance. This includes development of test plans (food migration, extraction, residuals testing, tox testing under Good Laboratory Practices (GLP)), updates of supplier questionnaires, updates of Substances of Interests (SOIs), etc
Qualification
Required
8+ years of in Product Regulatory or Product Stewardship
General knowledge of Polymers product lines, manufacturing processes, uses, etc. Proficiency an asset
Proficient in international chemical control, hazard communication, critical regulations (i.e. food contact, medical device, cosmetic, etc.) to conduct complex analysis of Polymers products and raw materials for global compliance
Ability to effectively collaborate and communicate within the organization, with customers, industry organizations, consultants, test labs and government agencies
Ability to devise, communicate and execute plans to meet tactical and strategic goals for global expansion and commercialization
Ability to lead and perform internal audits, ideally under GMP, RC and ISO 9001
Project Management and Continuous Improvement skills and use of tools an asset
Strong proficiency with Microsoft tools (Word, Excel, CoPilot) an asset
Bachelor's degree in Chemistry or related field required
Company
Kraton Corporation
Kraton develops, manufactures and markets biobased chemicals and specialty polymers that deliver exceptional value and enhance the lives of people all over the world.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1BKey Investors
Korea Development Bank
2024-07-11Post Ipo Debt· $1B
2021-09-27Acquired
2009-12-17IPO
Leadership Team
Marcello Boldrini
Chief Executive Officer and Board Director
David C.
Senior Process Engineer - CTO Refining
Recent News
2026-01-07
2025-10-24
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