Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07260 About our client Our client is a publicly traded global pharmaceutical company that is focused on the development, manufacturing and distribution of innovative generic drugs across a wide array of therapeutic areas. They boast exceptional revenue growth, an experienced management team and products that are well positioned in their core segments. This is a unique opportunity for someone that wants to put their drive and initiative to work! Position Location Regulatory Associate NJ Salary Highly competitive package, commensurate with experience Responsibilities 1) Support Regulatory Managers in the day to day activities to ensure the timely submission of responses, amendments, supplements and annual reports/updates to the FDA 2) Coordinate multiple projects and work independently to assemble and review ANDAs 3) Oversee post-approval ANDA life cycle 4) Interact with FDA Project Managers on a regular basis to monitor the status of applications 5) Coordinate in providing information related to the product related queries in a timely and efficient manner 5) Coordinate all information required for compilation of the drug product annual report 6) Ensure timely preparation of submissions including NDAs, ANDAs and DMFs (annual reports, supplements and responses to FDA questions) 7) Interact and support with other departmental colleagues including, but not limited to Marketing, Manufacturing, Business Development and Quality (compliance) 8) Aid in the review of labeling documents prior to FDA submission 9) Perform other activities as assigned by the Manager/Supervisor or Department Head Requirements 1) Bachelor’s degree in Life Science 2) Minimum 2 years of experience 3) Regulatory project management experience 4) Ability to work independently with minimal supervision 5) Time management skills and the ability to multi-task 6) A well-organized, detail & deadline-oriented individual 7) Good interpersonal skills with the ability to interact with staff on all levels 8) Excellent verbal & written communication skills 9) Willingness and ability to travel (to some extent)
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