Product Regulatory Affairs Specialist-Region Americas

• Supply product regulatory compliance for [Company] Region Americas

[Company] Calcium Carbonate Products

• Provide support to [Company] Region Americas in complying with local, state, federal, international and quasi-governmental associations with respect to Product Regulatory Affairs.
• Timely response to customer, distributor, regulator, staff, and other requests for product regulatory compliance information.
• Maintain various certifications and registrations (NSF, Kosher, FDA, etc.) of relevant facilities.
• Support sales, customer service, and other internal stakeholders to clarify various product regulations and provide regulatory oversight for sales.
• Assist in the preparation and maintenance of Material Safety Data Sheets in EHS module of SAP.
• Review all product bags / tags / labels per applicable requirements. This includes review of artwork, formatting, and language of various product labeling and ensuring that labeling is consistent among production facilities.
• Maintain communication with all locations to keep abreast of product regulatory affairs activities.
• Ensure that FG and/or USP products comply with applicable monographs.
• Support product compliance with various national and global product and/or substance regulations (e.g. FDA, EU Directives, national chemical inventory lists such as TSCA, etc.).
• Keep informed and educated about various regulatory changes through membership with trade associations, email notifications, etc.
• Work with suppliers, [Company] Purchasing Department, and production managers to ensure that products remain in compliance with relevant regulations

Supply Chain

• Review and confirm the approved product regulatory status of proposed product chemical components and prior to their incorporation into production.

Distributed Products

• Support the product regulatory review and approval process of new products into the [Company] sales pipeline.
• Review MSDSs and other regulatory documentation for imported and/or Distributed Products.
• Support the regulatory requirements review process of imported or Distributed Products.
• Ensure that MSDSs, labeling, and other documentation of imported products is compliant with applicable standards.
• Determine other regulatory consequences of imported products (TSCA, DSL, DOT requirements, etc.).

Other

• Other duties as assigned.
• Occasional Travel.

Candidate Profile Requirements

• A minimum of 5 years successful product regulatory work experience. A B.S. in natural, physical, toxicological, or environmental sciences.
• The incumbent must have excellent interpersonal skills. The incumbent must also have the ability to understand and clearly communicate complex, constantly evolving regulations verbally and in writing to executive management or staff.
• Written and verbal fluency in English is mandatory. Written and verbal proficiency in Spanish and/or Portuguese is desirable.
• Working knowledge of SAP EHS Management application preferred.