Sr Regulatory Affairs Specialist at Tephra Inc
Posted in Management 30+ days ago.
This job brought to you by eQuest
Location: Pittsburgh, Pennsylvania
The primary responsibility of this role is to ensure Our Client’s products and procedures meet the requirements of the Toxic Substances Control Act (TSCA). This includes interpretation of new regulations resulting from the Frank R. Lautenberg Chemical Safety for the 21st Century Act, implementing compliance strategies to support the sale of new and existing products, as well as implementing procedures for TSCA reporting requirements. This role will also include support for other regulatory areas such as FDA and DEA regulations.
Candidate Must Have:
- Degree in Chemisty, Biology, toxicology
- experience with TSCA
- Strong knowledge of polymer chemistry
•Evaluate chemical compositions of Our Client’s products and raw materials to determine regulatory status under TSCA
•Prepare required documentation for Pre-Manufacturing Notification filings under TSCA, including technical, marketing, environmental, customer use and health and safety data
•Analyze and interpret proposed and final EPA rulemaking under TSCA published in the Federal Register
•Send TSCA R&D disclaimer letters to customers receiving samples of non-TSCA listed chemicals
•Respond to customer inquiries regarding US and global marketability of Our Client products
•Prepare and submit reports to EPA required by relevant sections of TSCA
•Maintain systems to meet TSCA recordkeeping, reporting and notification requirements.
•Assist other members of Product Safety and Regulatory Affairs as needed.
•BS degree in Chemistry or related technical discipline (e.g., toxicology, biology) with at least 4 years of experience
•MS degree with at least 2 years of experience OR PhD with at least 1 year of experience
•MS or PhD Chemistry degree
•Experience with or knowledge of TSCA regulations
•Experience with SAP computer systems
•Experience or familiarity with FDA indirect food additive regulations
Essential Knowledge and Skills:
•Detail-oriented with excellent communication skills
•Strong knowledge of polymer chemistry