Regulatory Affairs Manager

Regulatory Affairs Manager-The Manager will provide regulatory support and guidance for projects from inception through development and post-approval work for various types of submissions to ensure the submissions are handled on time. The Manager will compile documentation and will write Module 2/Module 3 eCTD sections for ANADAs, PASs and CBE-30s. The incumbent will develop CVM meeting requests, assist with launch initiatives and  assess change controls for both drug substance and drug product. The Manager will utilize a thorough understanding of FDA requirements and processes to support multiple products/projects at the same time.

Qualifications include 5-8 years of experience with FDA regulations; CVM experience is preferred. Other qualifications include a working knowledge of pre and post approval submissions for solid oral and injectable dosage forms, API’s, cGMPs, ability to travel 15% of the time and familiarity with ADE/PQC (PV Works) regulations and electronic document publishing to support regulatory submissions is helpful. The successful candidate will be self-motivated, detail oriented, collaborative and able to multi-task. Excellent communication skills are needed.

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