ORGANON, LLC – $66,414.00/Year

Must have a Masters degree in Regulatory Affairs. Must have 2 years experience in regulatory affairs in a pharmaceutical company andor CRO in pharmaceutical industry. Must have experience in compilation, preparation, strategy, review and submission of regulatory submissions for marketing authorizations in various global markets. Must have thorough knowledge of clinical research documentation such as ICF, FDA 1571, 1572; quality and clinical regulations such as CFR Title 21, ICH, WHO guidelines, GMPs, GLPs and GCPs; skills such as Excel, PowerPoint, and SharePoint. 40 hrs per week 9am5pm. Must have proof of legal authority to work in the United States.