Regulatory Affairs Specialist I

Job Description
The Regulatory Affairs Specialist I will support the day-to-day regulatory activities and operations of assigned projects. These include assisting with the preparation and compilation of
submissions for regulatory agencies, supporting the management of regulatory
operational processes and timelines, and maintaining regulatory tracking tools, archives, and infrastructure, as assigned.

Primary Duties and Responsibilities:
• Support the review, finalization, and internal sign-off of regulatory notifications.
• Assist with commercial product notification activities as assigned.
• Support the notification process by gathering data, preparing draft documents,
routing materials for review, assisting with final submissions, and maintaining submission records.
• Maintain tracking logs for regulatory notifications, submissions, and approvals.
• Support preparation, submission, and tracking of documents for license and
registration renewals (...