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Search underway for a Regulatory Affairs Associate to join our client, a pharmaceutical company.
- Providing support for post marketing related update for IND/NDA
- Providing support for CMC submissions and input for CMC related changes
- Providing support for review of technical documentation including specification, product development, process validation, analytical test method and stability data prior to FDA submission
- Coordinating review of labeling and promotional materials, and maintaining files
- Assisting in the preparation of regulatory submissions and maintaining central files
- Assisting in the preparation and review of technical transfer packages and ensuring compliance with the registered application
- Interfacing with internal and external partners to ensure Regulatory Compliance requirements are met
- Assisting in preparation of presentations to the management team
- Preparing labeling and regulatory change controls and managing review and approval process
- Bachelor Degree
- 3-5 years of experience within pharmaceutical regulatory affairs
- Sterile and injectable product experience is required
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Project)
- Proficiency in use of databases