INDUSTRY: Chemicals

LOCATION: Fort Washington, PA

CONTEXT: Our client, a global chemical company, is seeking a Regulatory Affairs Specialist to oversee the safety and regulatory compliance of all company products and processes through the implementation, documentation and maintenance of regulatory programs and systems.  This position reports to the Health, Safety, and Environmental Product Manager.

RESPONSIBILITIES

• Provide timely and appropriate 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.
• Manage Chemical Inventory Compliance (TSCA, DSL/NDSL, MERCOSUR), including CDR reporting, CBI Claims, PMN submissions, 12(b) notification, etc.
• Provide Health/Environment/Safety (HES) expertise on hazard assessments and product application reviews of new and current product evaluations (Food contact, Automotive, Fiber etc.).
• Advise and communicate on hazardous material transportation requirements and Harmonized Tariff Schedule codes.
• Implement and maintain 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, Sales, Supply Chain and Customer Service.

REQUIREMENTS

• Bachelor's Degree in a relevant field of study (chemical / biology / environmental engineering, health science/toxicology, or chemistry/biology/ environmental/ occupational science).
• In depth knowledge of relevant regulatory standards and laws related to the use of chemicals, specifically Food Contact Regulations, Inventory Compliance, Transportation Regulations as well as a knowledge of product risk management. Food contact migration calculation and testing experience preferred.
• 5+ years of experience in product safety, regulatory affairs or related area.
• Practical knowledge of polymer chemistry and/or polymer physics.
• Experience with authoring SDSs using SDSs authoring web based software.
• Experience working in polymer/compounding production.
• Product composition review experience for sensitive applications (food contact, medical device and/or pharmaceutical packaging), and submission of DMF type IV (Drug Master File) through eCTD portal.
• Strong interpersonal, written and oral communication skills, and must be capable of interacting with diverse groups at all technical levels such as customer service, plant personnel, R&D, customers, technical consultants, contractors, etc.
• Demonstrated ability to work independently as well as a part of a diverse team.
• Effective written and verbal communicator, in both one-to-one and group discussions.
• Current proficiency in standard office software (i.e., Microsoft applications, Excel, and SalesForce (CRM)), as well as, the ability to learn specialized applications such as SAP.
  
• Ability to research and interpret regulations.
• Ability to build internal database of knowledge of US regulatory compliance (OSHA, TSCA, etc.).
• Ability to travel occasionally.