Leading global chemical manufacturer is seeking a Product Regulatory Affairs Specialist. This position will be based in Fort Washington, PA and is not elligible for relocation assistance. Candidates must have experience with 21 CFR, Chemical Inventory compliance, hazard communication codes, authoring SDS and HSE experience. In depth, knowledge of relevant regulatory standards and laws related to the use of chemicals. Specifically Food Contact Regulations and Inventory
location: Fort Washington, Pennsylvania
job type: Permanent
salary: $80,000 - 95,000 per year
work hours: 8am to 4pm
- Providing timely and appropriately responses to product safety and regulatory affairs inquiries from internal and external customers
- Evaluate Food Contact Compliance as it relates to: 21 CFR, Health Canada and MERCOSUR
- Oversee additional FDA initiatives within the company o Register site(s) and partner with the FDA and/or consultants to manage FDA projects and Project management for any potential Food Contact Notifications
- Manage Chemical Inventory Compliance (TSCA, DSL/NDSL, MERCOSUR) o Including CDR reporting, CBI Claims, PMN submissions, 12(b) notification, etc.
- Provides Health/Environment/Safety (HES) expertise on hazard assessments and product application reviews of new and current product evaluations (Food contact, Automotive, Fiber etc.).
- Advises and communicate on hazardous material transportation requirements and Harmonized Tariff Schedule codes.
- Implementing and maintaining hazard communication requirements.
- Including authoring SDS in various languages within cross-functional teams and control/archive evidences.
- Provide guidance in product physical and health hazard test for hazardous classification.
- Monitor, interpret, communicate, and assess business impact of emerging technical and regulatory issues from the Americas for the business.
- Represent company on external trade groups and teams to support business objectives.
- Be a key supporting player for Product Stewardship, Research & Development, NA and SA Sales, Supply Chain and Customer Service
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors (required)
- Regulatory Affairs / Compliance (5 years of experience is required)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.