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Job Title: Manager/Director, Regulatory Affairs
Description:
The Manager/Director, Regulatory Affairs will provide US regulatory stewardship for the assigned development candidate(s), serving as Cougar's regulatory liaison with FDA Division staff responsible for the assigned product(s).
Responsibilities include the following:
- Develop US regulatory strategy in support of the Global Regulatory Plan
- Provide US regulatory intelligence assessments in support of assigned therapeutic area
- Contribute to development of IND/NDA original documents and amendments intended for submission to FDA to ensure compliance with US regulatory strategies and requirements
- Manage FDA meetings for assigned product, including development of required documentation
- Collaborate with the Global Regulatory Team and Clinical Study Team for assigned project
Qualifications:
Candidates should have a minimum of a Pharm D or undergraduate degree in a life science with 3 - 5 years of US pharmaceutical industry regulatory experience. An advanced degree is a plus. Required qualifications include demonstration of successful submissions/management of INDs/NDAs/BLAs and extensive knowledge of US FDA regulations and guidelines, including ICH. Sound planning and strategic skills, as well as excellent leadership, communication, and organizational skills are also required.
Compensation:
Commensurate with experience
Date Posted: 05/08/2008
Email Résumé to info@cougarbiotechnology.com
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
