Product Stewardship and Regulatory Affairs Sp

AGC Chemical Americas$75K — $95K *
Exton, PA 19341In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in chemistry, materials science, or related disciplines; Master's degree preferred
  • 5-7 years of experience in regulatory affairs and product safety (TSCA, FDA)
  • Strong background in chemistry, especially polymer chemistry; organofluorine chemistry experience desired
  • Proficiency in standard office software and ERP systems
  • Willingness to travel up to 15% (domestic and international)

Responsibilities

  • Support new product registrations in the Americas region, coordinating with R&D and global teams
  • Collaborate with technology, manufacturing, and procurement teams for product stewardship reviews
  • Engage with overseas colleagues and legal teams on customer declaration requests
  • Manage the SDS system and generate SDS for the Americas region
  • Oversee FDA food contact product portfolio and support FCN submissions
  • Advocate for product safety and stewardship with trade associations and government agencies
  • Monitor regulatory changes and assess their business impact

Benefits

  • Part of a global, interactive, and diverse team
  • Opportunity to influence product safety initiatives
  • Exposure to cross-functional collaboration with various departments
  • Potential for professional growth in regulatory affairs
  • Engagement with international product stewardship practices
Full Job Description
The product stewardship and regulatory affairs specialist will support the Company's needs for compliance within the Americas region. The position is part of a global highly interactive, diverse, and supportive team and will manage product stewardship activities to enable sales of new products and maintain the right to operate with existing products. Essential Functions: • Supports new product registrations for Americas region, e.g., TSCA PMN/LVE/Polymer Exemptions, and Canadian DSL/NDSL notifications in close collaboration with R&D and global product stewardship teams. Coordinate TSCA 8c and 8e reviews. • Works closely with technology, manufacturing, commercial, and procurement functions to ensure product stewardship reviews are conducted for raw material and product introduction within the region. • Engages with overseas Product Stewardship colleagues and legal to address Customer declaration requests within agreed business deadlines. • Manages the SDS system with EHS manager and generate SDS' for the Americas region, in collaboration with Japan, for commercial and R&D products. • Manages the FDA food contact product portfolio and support new Food Contact Notification FCN submissions. • Supports the Product Stewardship Manager in efforts to effectively advocate the Company's product safety and product stewardship positions with trade associations, government agencies and non-governmental organizations. • Supports the supply chain department with Export control clearance and TSCA export notification. • Supports the procurement department with TSCA import clearance. • Monitors regulatory changes and assess and communicate their impact to the business based on an expert understanding of international Federal and state laws. • Responds to complex internal and external customers Product stewardship requests. Must be able to escalate to a more knowledgeable and experienced member of the team. • Conducts training for company research and development, commercial, customer service, manufacturing personnel, and customers on regulatory affairs and product safety topics related to the company products' compliance. • Supplies necessary support to the legal team when necessary. • Other projects and duties as assigned. Qualification and Skills: • Bachelor's degree in chemistry, materials science or related disciplines Master’s degree preferred. • Five to seven years working knowledge in regulatory Affairs and Product Safety TSCA, FDA, etc. • Strong chemistry background. Experience with polymer chemistry is needed. Organofluorine chemistry knowledge/experience desired. • Proficient in standard office software and ERP systems. • Willing to travel up to 15% (domestic and international). Physical Requirements: Physical Requirements: • Must be able to remain in a stationary position for extended periods. • Needs to occasionally move about inside the office to access office machinery, accomplish tasks, or travel from one worksite to another. • Constantly operates a computer, keyboard, copier, printer, and other office productivity machinery. • No adverse environmental conditions expected.

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