A Senior Associate, Regulatory Affairs job near Mahwah, New Jersey is available courtesy of Adecco Medical and Science. Suitable candidates will have least three years of experience in CMC Regulatory Affairs and experience writing ANDAs for FDA submission.
Senior Associate, Regulatory Affairs job responsibilities include:
• Preparing and writing ANDAs and other approval materials, including but not limited to PAS, CBEs, and annual reports, for submission to the FDA
• Developing professional relationships with FDA personnel to help ensure organization adheres to laws and regulations, and receives proper guidance.
• Creating and maintaining databases, and updating tracking systems related to FDA submissions.
Senior Associate, Regulatory Affairs job qualifications include:
• Bachelor's Degree or higher applicable to the pharmaceutical field, preferably within Regulatory Affairs
• CMC Regulatory Affairs and ANDA experience
• Must have strong working knowledge of Microsoft Office and eCTD publishing tool
If you are interested in this Senior Associate, Regulatory Affairs job near Mahwah, New Jersey then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com. If you have questions about the position please contact Jonathon Blauvelt at email@example.com.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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