Abbott Laboratories - Los Angeles, CA
posted 4 months ago
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. We are currently hiring a Regulatory Affairs Operations Specialist I to work on-site at our Sylmar, CA location. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, this role will support necessary regulatory activities required for product market entry. Daily responsibilities include supporting product releases by preparing Global Trade Services (GTS) licenses for products, countries, and business partners, allowing shipment of products to achieve departmental and organizational objectives. The specialist will be responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs), and tender support, as well as overall regulatory operations activities. A full working knowledge of GTS license types, country regulatory, and language requirements is essential. The role also involves providing support for Product and Country Experts in the setup for the release of new and modified products globally. Acting as a regulatory representative, the specialist will review and analyze GTS blocked orders, providing guidance and direction on regulatory compliance. The position requires reviewing and evaluating customer service requests and monitoring email communications, ensuring all communications convey necessary details and adhere to applicable regulatory standards. Maintaining positive and cooperative communications and collaboration with all levels of employees worldwide, customers, contractors, and vendors is crucial. The specialist will also need to have a basic understanding of the product lines being supported and a full understanding of Windchill and SAP applications for research, problem-solving, and analysis of blocked orders and creation of GTS licenses. This position represents Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates, and IT. The specialist will support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Compliance with U.S. Food and Drug Administration (FDA) regulations, international regulations, and other regulatory requirements, company policies, operating procedures, processes, and task assignments is mandatory. Participation in projects affecting GTS licenses and performing other related duties and responsibilities as assigned is also expected.