Regulatory Affairs – Drug Master Files Job in Mahwah, New Jersey US
Saturday, November 13th, 2010Regulatory Affairs SpecialistPharmaceutical There is an immediate need for a Regulatory Affairs Specialist with pharmaceutical experience in the northern New Jersey area.
The company needs someone with regulatory experience in pharmaceutical drug development and manufacturing.
Experience with Drug Master Files (DMF), NDA and aNDA submissions, and exposure to both US and international Regulatory Affairs issues involving pharmaceutical products is required.
Additional experience in combination devices or simply medical device RA such as 510k submissions is a huge plus.
This is a strong and growing company with excellent promotability and benefits.
In this role you will have the opportunity to be a part of the product development team working on combination products with engineering and quality professionals on both sides of the device and pharmaceutical regulations to insure products in the pipeline are in compliance.
QUALIFICATIONSBS/BA minimum.
Advanced degrees are a plus.
5+ years experience in Regulatory Affairs of medical devices Experience managing a team of Regulatory Specialist and Associates Drug Master File experienceBroad knowledge of pharmaceutical regulations and standards There is a relocation package available for the right candidate.
Please respond to this advertisement by attaching your resume in MS Word format to an email addressed to john [at] mriatl [dot] com and John Boynton at MRI Atlanta Peachtree North will give you a call if you meet the requirements.
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Regulatory Affairs – Drug Master Files Job in Mahwah, New Jersey US