Product Stewardship and Regulatory Affairs Specialist Lead

2 days ago


Downingtown, Pennsylvania, United States AGC Chemical Americas Full time
Unlock Your Potential in Product Stewardship

We are seeking a highly skilled Product Stewardship and Regulatory Affairs Specialist Lead to join our team at AGC Chemicals Americas. As part of our global subsidiary, you will have the opportunity to collaborate with great people, gain an important international perspective, and be part of a network of thousands of colleagues worldwide.

This role offers a unique blend of regulatory affairs and product safety expertise, requiring a strong understanding of international frameworks, excellent communication skills, and a passion for ensuring product safety. You will support the company's needs for compliance within the Americas region, managing product stewardship activities to enable sales of new products and maintain the right to operate with existing products.

Key Responsibilities:

  • Collaborate closely with technology, manufacturing, commercial, and procurement functions to ensure product stewardship reviews are conducted for raw material and product introduction within the region.
  • Lead new product registrations globally, coordinating TSCA 8c and 8e reviews, and working closely with R&D and global product stewardship teams.
  • Manage gas and solvent business regulatory compliance and advocacy, as well as FDA food contact product portfolio and support new Food Contact Notification FCN submissions.
  • Advocate the company's product safety and product stewardship positions with trade associations, government agencies, and non-governmental organizations, while supporting the procurement department with TSCA import clearance.
  • Maintain expert knowledge of international Federal and state laws, monitoring regulatory changes and assessing their impact on the business.
  • Generate SDS' in collaboration with Japan for commercial and R&D products, respond to internal and external customers' product stewardship requests, and conduct training on regulatory affairs and product safety topics related to the company's products' compliance.

Requirements:

  • Bachelor's degree in Chemistry, Materials Science, or related technology required; Advanced degree preferred.
  • Five to ten years working knowledge in regulatory affairs and product safety (TSCA, FDA).
  • Strong chemistry background, including experience with polymer chemistry, fluorochemistry, and fluorogases.
  • Knowledge of international regulatory programs is preferred.
  • Proficient in standard office software and ERP systems.

What We Offer:

  • A competitive salary of $120,000 - $160,000 per annum.
  • Medical, dental, and vision insurance.
  • Paid time off and paid sick time.
  • 401(k) safe harbor plan with company match; immediate vesting.
  • Student loan pay down/college save up.
  • Tuition reimbursement.
  • Fitness reimbursement.

AGC Chemicals Americas is an equal opportunities employer and does not discriminate based on race, color, sex, national origin, or ancestry, religion, age, disability, citizenship, marital status, military or veteran status, or any other prohibited basis.



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