Regulatory Inquiry Coordinator

Regulatory Inquiry Coordinator

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

Position Summary:

Will be answering regulatory type questions in a phone/email support role for internal commercial/strategic customers. Prefer college graduates with a scientific degree (Chemistry or Life sciences) to best understand the lines of business they will be supporting. Must be service oriented.

• Is responsible for customer quality and regulatory inquiry support and processing
• Ensures customer satisfaction for requested quality and regulatory documentation for focused sections of the Life science portfolio.
• SME for a specific portion of the product portfolio (including product technology and application)
• Implements procedures and methods to provide quality and regulatory product and service information.
• Business partner for the Commercial and Business Areas for customer inquiry processing
• Supports the resolution of data requirements to align with business expectations
• Interacts with Business, Commercial, IT, Ops, Supply Chain and other Q&R management.
• Utilizes e-tools used to manage inquiry processes, data, and trending/reporting

Qualifications

• Degree (e.g. pharmacist, chemist, engineer) that provides knowledge of theories, principles and concepts within Quality Management System
• Requires professional experience (approximately 1 -3 years)
• Requires knowledge of market, competitors and technological processes
• Requires knowledge on a broad scope of quality and regulatory standards
• Strong skills/knowledge in Enterprise systems, i.e. SAP
• Excellent communication and relationship skills