Senior Specialist, Product Regulatory

Make a +Difference at Kraton!

At Kraton, we make a Positive Difference, and we are looking for individuals who are also looking to make a difference in their jobs, for our customers and to the world.  We are looking to hire a key member of our team at our  Global Headquartrers located in The Woodlands, Texas. 

The Senior Specialist, Product Regulatory is responsible for working with internal stakeholders as needed to ensure Kraton Polymers’ product portfolio (raw materials, products, byproduct manufactured, imported or distributed) is in compliance with regulatory and industry standards in the Americas (primarily the US) along with some Global oversight. 

Key Responsibilities

• Act as subject matter expert for sensitive applications in the following Polymers intermediates markets:
  • Food contact - FDA, Mercosur, ANVISA
  • Medical Devices - FDA Drug Master Files (DMF), Pharmacopeia, etc.
  • Cosmetics - INCI, industry standards such as Leaping Bunny, etc.
  • Other sensitive markets - such as Personal Hygiene and Toys
• 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.

Required Skills

• 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

Education, Certifications & Licenses

• Bachelor's degree in Chemistry or related field required.

--------------------------------------------------

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification.  Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Kraton’s internal talent acquisition team manages our recruiting efforts and from time to time works with pre-selected/pre-approved external staffing agencies. We do NOT accept unsolicited resumes or candidate referrals from recruiters and/or agencies who are not pre-selected/pre-approved.

Kraton is proud to be an Equal Opportunity Employer.