Regulatory Submissions Manager
- Job ID:
- Date:09/23/2008
- Location:Cincinnati
- State:Ohio
- Salary:Not Specified Why?
- Job Types:
-
REGULATORY AFFAIRS
Job Description
Medpace, Inc. is a growing contract research organization based in Cincinnati that manages clinical trials for pharmaceutical companies. Due to growth, we are currently seeking a Regulatory Submissions Manager to coordinate, prepare, and assemble INDs, CTAs, NDAs, CTDs, and FDA meeting packages.
Job Duties:
Leads the coordination, preparation, and assembly of INDs, CTAs, NDAs, CTDs, and FDA meeting packages
Prepares for key meetings with the FDA and other Regulatory Authorities
Provides regulatory advice and guidance to project teams to ensure submissions meet domestic and international regulatory requirements
Works closely with preclinical, clinical, and CMC groups from the initial process of defining regulatory requirements and strategies
Reviews clinical trial and marketing submissions for regulatory compliance and accuracy
Serves as a primary liaison between the company and Regulatory Authorities
Provides regulatory review of study protocols, investigator's brochures, labeling, and integrated summary documents
Maintains up-to-date knowledge of FDA requirements
Qualifications:
Candidate must have a BA/BS in Life Sciences with 8 to 10 years of experience in Regulatory Affairs or a Masters degree with 5 years of experience
Experience with FDA submissions, including INDs and NDAs
Experience with international submissions is desired
Experience with electronic submissions is a plus
Working knowledge of requirements for INDs, NDAs, CTAs and CTDs required
Travel: None
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