The Client is a mid-size pharmaceutical company, located on the Peninsula, that focuses on HIV and Liver disease. This role is a 40 hour/week contract position, no work from home options, and no relocation expenses available. Job Description: Represent Regulatory Affairs on internal and external cross-functional teams (e.g., SMT) Providing regulatory affairs support and strategy for investigational and/or marketed products for HIV, as assigned. Responsible for IND and NDA submissions for assigned products, which may include routine submissions (e.g., safety reports, DSUR, PSUR/PBRER, and NDA Annual Reports) as well as IND amendments and NDA supplements, as needed. Potential opportunity to support compilation and submission of a new INDs or NDAs. Work within the department and with other functional areas on process improvements. Work Environment/ Qualifications: Minimum of a BA/BS degree; a Master's degree is desirable Minimum 4 years of experience in Regulatory Affairs or related field within Biotech or Medical Device Ability to work independently on multiple projects with tight timelines is important. Work is performed under minimal supervision of a Regulatory Affairs professional. General understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories. If you feel like you have 75% of these qualifications, please feel free to apply to this position. If you have a similar skill set and would like to send your resume for other opportunities, feel free to email me directly. Do not call regarding this position. All inquiries should be sent through email. About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com. Aerotek is acting as an Employment Agency in relation to this vacancy. ()
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