Regulatory Affairs Specialist
- Job Level:
$68,000 - 72,000 plus Bonus
Our client is hiring for a Regulatory Affairs Specialist in Shelton, CT. In this role, you will assist in ensuring regulations and compliance for manufactured and distributed specialty chemical products, nutraceutical, health and personal care, cosmetic and pharmaceutical ingredients.
As the Regulatory Affairs Specialist, you will:
- Work with Regulatory & Compliance Manager to ensure full compliance with federal, state, local regulations and corporate standards.
- Assist in creating and maintaining SDS’ and labels in the ExEss software (ERP), ensuring compliance with current country specific GHS and per various government agency. regulations. You will also participate in existing project to update the database in ERP system and automate SDS/labels authoring software.
- Responsible for entering/updating new parts in IFS database with corresponding regulatory information and documents.
- Work with our NACD (National Association of Chemical Distributors) team that is responsible for updating and maintaining internal Responsible Distribution policies and procedures.
- Utilize company’s compliance software program, to assist in creation of EHS programs (OSHA Hazcom 2012).
- Assist with tariff rate classification and compliance with various government agency regulations such as EPA (TSCA) ad FDA for our imports.
- Participate in annual physical inventory counts and reconciliations for 3rd party warehouses, including compliance safety audits.
- Assist in customer requested warehouse audits to ensure customer/product standards are met per cGMP.
- Assist with database management for INFOTRAC (main 24-hour contact for transportation spills) ensuring updated SDS’ and labels are on file.
- Participate in internal Import Audit project involving updating of regulatory import data in ERP system while working with Import team and Regulatory & Compliance Manager to determine the necessary regulatory updates.
- Assist in the completion of Quality, Regulatory, Safety questionnaires for Customers and Suppliers in coordination with the Sales Support, Product Managers and Regulatory & Compliance Manager.
- Assist in the auditing of distribution and manufacturing processes to ensure process safety.
- Participate in training internally and externally on Responsible Distribution, Regulatory & Compliance, OSHA, Hazmat, GHS and other as required.
- Assist with the reviewing, reconciling, and approving vendor invoices such as freight, warehouse handling and custom broker bills.
- Backup other regulatory/compliance functions, and other projects as assigned.
Experience & Skills Required
- Bachelor’s degree in Chemistry (or related field)
- 2-3 years regulatory compliance experience specific to chemicals, food and/or drug industry is highly preferred
- Hazmat and GHS trained is desired
- FDA, EPA, EHS experience is a plus
- Strong IT skills (MS Office, Outlook, Word, Excel, PowerPoint), experience in IFS and ExEss software a plus
- Willing to travel as needed.