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Regulatory Affairs Specialist I Regulatory Affairs Specialist I
Ref No.: 17-15363
Location: Swiftwater, Pennsylvania
Regulatory Coordinator
The primary responsibilities of this position are detailed as follows:
• Contribute to Authoring/revision of product and country specific documentation (Product License Commitments (PLCs) and International Licensing Variation Forms (ILVF))
• Contribute to preparation, review and/or edit of new registrations and variations for bacterial and viral products
• Assure submission files, communications, questions etc. are properly archived and tracked in RA systems on a real-time basis as required
• Assist with gather and tracking of department metrics

Knowledge and understanding of United States (FDA) and international regulations/guidelines,
• Strong working knowledge of Microsoft Office (especially Word, Excel).
• Experience with or ability to learn regulatory affairs department systems (e.g. document management and tracking systems)
• Must be able to work independently
• Must be productive, demonstrate the ability to deal with multiple tasks and be able to prioritize tasks with the supervisor input
• Excellent written and oral communication skills