Must have a Masters degree in Regulatory Affairs. Must have 2 years experience in regulatory affairs in a pharmaceutical company. Must have experience in preparation, review and submission of regulatory submissionsdocuments to FDA in compliance with regulatory guidelinesrequirements andor applicable federal laws. Must have thoroughbr knowledge of Chemistry, Manufacturing Control CMC regulatory affairs, preparing INDs and NDAs, FDA regulations and regulatory compliance and enforcement. 40 hours per week 9am5pm. Must have proof of legal authority to work in the United States.
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