Principal, Regulatory Affairs - Combination Products Development (Remote)
Job Summary: The Regulatory Affairs Principal is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing global submissions including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking or those associated with NDAs, BLAs, MAAs. The Principal ensures timely and high-quality execution of all regulatory deliverables. In addition, the Principal mentors team members, and provides support for global regulatory approvals (beyond US and EU), commercialized products, and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.
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