What are the responsibilities and job description for the Regulatory Affairs Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities : Administrate Error and Accident (Deviation) procedure and process; perform all required data entry, paperwork, file maintenance, written and verbal communications, and follow up within the required time constraints. Oversight of data entries in the GBS DDL. Assist Regulatory Management with product deviation reporting to the FDA. Updates and distributes annual facility FDA reports. Help management ensure compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to deviation management. Maintain updated CFR access for donor center and manufacturing operations. Coordinates Deviation management process to ensure timely reporting and closure for GBS whole blood, source plasma and manufacturing operations. Performs review of Deviation Reports and associated documentation to ensure completeness, including documented evidence of impact assessments as a part of risk management and completion of all CAPA actions required by the report have occurred. Requirements : Intermediate to advanced computer skill in Microsoft Word, Outlook, Excel. Advanced understanding of Good Manufacturing Practices (GMPs), FDA & EU Regulatory requirements. Excellent interpersonal and communication skill. Must possess customer service skills and display attention to detail. Experience with Deviation Management system a plus. Must be flexible and able to multi-task in a fast-paced environment, and team player. Must be able to proof work and identify non-standard format or wording and errors within documents.
