Regulatory Affairs Specialist - Specialty Chemicals
Job Description
Job Description
The Regulatory Affairs Specialist plays a critical role in ensuring AGCCA's products comply with international, federal, and state regulations. This position will focus on new product registration with a strong emphasis on compliance with the Toxic Substances Control Act (TSCA) and other global regulatory frameworks. . This position supports 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. The ideal candidate will have a educational background in chemistry and a solid background in regulatory affairs within the chemical industry.
Key Responsibilities:
- Work 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, e.g. TSCA PMN/LVE/Polymer Exemptions, Canadian DSL/NDSL notifications, in close collaboration with R&D and global product stewardship teams. Coordinate TSCA 8c and 8e reviews.
- Manage the gas and solvent business regulatory compliance and advocacy.
- Manage the FDA food contact product portfolio and support new Food Contact Notification FCN submissions.
- Support 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.
- Support the procurement department with TSCA import clearance
- Monitor regulatory changes. Assess and communicate the impact to the business based on an expert understanding of international Federal and state laws.
- Generate SDS’ in collaboration with Japan for commercial and R&D products.
- Work closely with overseas Product Stewardship colleagues and legal to address Customer declaration requests within agreed business deadlines.
- Respond to internal and external customers Product Stewardship requests. Must be able to escalate to a more knowledgeable and experience member of the team.
- Conduct 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.
- Provide necessary support to legal team when needed.
Job Requirements:
- Bachelor’s degree in Chemistry, Materials Science or related technology required, Advanced degree preferred.
- 3 - 5 n years working knowledge in regulatory Affairs and Product Safety TSCA, FDA…
- In-depth knowledge of TSCA, including new substance registration processes.
- Strong chemistry background, including experience with polymer chemistry is required.
- Fluorochemistry, Fluorogases knowledge/experience is required.
- Experience with global regulatory systems is highly desirable.
- Strong analytical and organizational skills, with keen attention to detail
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively in a fast-paced, cross-functional environment.
- Proficient in standard office software and ERP systems.
- Willing to travel up to 15%.
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.
What's in it for You:
- Opportunity to work with a globally recognized leader in the chemical industry.
- Bonus eligible
- Comprehensive benefits package.
- Inclusive and innovative company culture.
AGC Chemicals Americas is a global subsidiary of AGC Inc., a multinational corporation and one of the world’s largest manufacturers of glass, electronic displays, and chemical products. Headquartered in Exton, Pennsylvania, including a state-of-the-art technology center, AGC Chemicals Americas maintains manufacturing operations in nearby Thorndale, Pennsylvania, a satellite sales office in Sao Paulo, Brazil and warehouses located throughout North America.
AGCCA provides you with the opportunity to collaborate with great people. As part of a global company, you will gain important international perspective and will be part of a network of thousands of colleagues worldwide while enjoying the small-company environment where you can see the impact of the company's success.
AGCCA does not discriminate based upon race, color, sex, national origin or ancestry, religion, age disability, citizenship, marital status, military or veteran status, or any prohibited basis. This commitment applies to all aspects of the employment relationship, including hiring, promotion, compensation, discipline, discharge, and any term or condition of employment. All employment decisions are made, and all personnel policies construed in compliance with all applicable federal, state, and local anti-discrimination laws. All unlawful discrimination is prohibited.
This position does not support visa sponsorship.
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