Regulatory Affairs / QA

Regulatory Affairs / QA Location: DC-Washington Job Code: 715 # of openings: 1

Description Provide subject matter assessment of regulatory submissions with particular input regarding early product development aspects of contracted activity, to assist in identifying deficiencies or problems regarding clinical issues prior to submission to the FDA. Review and assess product development related documentation, presentations and meeting proceedings to provide regulatory issues input during the entire product development process with particular emphasis on clinical study-related activities; provide clinical study subject matter expert advice and guidance on dealing with regulatory and/or quality assurance issues involving the contracted countermeasure sponsor, the FDA, CDC, NIH, and DoD cooperative projects, including meeting proceedings and possible site visits/audits (inspections). In some instances may interface with relevant FDA Centers regarding clinical studies aspects of regulatory and/or quality assurance issues associated with the product development throughout the investigational, advanced development, approval, and post marketing phases of countermeasure development; conduct site visits, as needed, in accordance with FDA regulations and FAR/HHSAR regulations, pertaining particularly to aspects of product clinical development, including but not limited to clinical study planning design, execution and reporting, and post approval regulatory requirements. Qualifications: *  Masters degree or PhD/MD/PharmD *  Minimum of 5 years of experience in FDA-regulated drug, medical device and/or biologics industry including significant experience directly involved with early product development aspects such as preclinical research, toxicology and animal modeling.

Please refer to job code harborlight-715 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Washington, DC
County:	District Of Columbia County
ZIP Code:	20001
Pay Rate:	Open
Job Terms:	full time
Company:	Harbor Light Recruiting, Inc.
Phone:	email only please
Fax:	email only please