US-NJ: Titusville-Regulatory Liaison
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Job Title: Regulatory Liaison
Job Location: NJ: Titusville
Pay Rate: $40.00 - $60.00
Job Length: full time
Start Date: 2004-05-18
Company Name: Fladger and Associates
Contact: Michael Fladger
Phone: mfla...@comcast.net
Fax: Email please
Description: . Oversees preparation of background documents and routine submissions. Maintains US IND. Review and approve clinical trial material requests. Interprets regulations and guidance documents to advide Global Regulatory Leader and teams regarding regulatory requirements and trends in the region represented. Travel is required for FDA meetings, team meetings and professional meetings.
Provides US regulatory strategic input for the US/Canada to the Global Regulatory Leader. Identifies regional issues affecting regulatory strategic plan. Develop Orphan Drug applications and Pediatric Exclusivity Requests. Ensures that submission to the FDA are assembled and that the submission are of quality.At least 5 years experience. Bachelors degree required. Thorough working knowledge of US regulatory requirements and guidelines for the US; international experience desirable. Previous experience with FDA required with background in developing regulatory strategies. Strong communication, organizational and negotiating skills are essential. Oncology experience preferred.Please send resume in ms word format.
Please send to attention of Mr. Michael Fladger.
Required Skills: Operations Research
This job is unknown.
Job Type: Manager, Project Leader
Please refer to Job code 2163341 when responding to this ad.
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