Regulatory Inquiry Coordinator

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.

• Key Individual Accountabilities / Deliverables
  
  • 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

• 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

Kind Regards,

Daniel Jagota

Technical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT 732-429-1919

daniel @irionline.com