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Job Title: Manager/Sr. Manager, Regulatory Operations
Description:
The Senior Manager, Regulatory Operations represents Regulatory Operations on regulatory project teams, serves as a primary contact to the FDA and other regulatory authorities related to regulatory submissions, and is primarily responsible for managing project deliverables and resources to meet Regulatory Affairs departmental goals. This position supports submission of Regulatory documents including the planning, scheduling and coordinating of Regulatory submissions and Safety reporting developments, based upon thorough knowledge of applicable regulations for electronic submissions and company procedures.
Qualifications:
The successful candidate will have a Bachelors degree in a scientific discipline, systems technology or equivalent; knowledge of US and Global requirements with regard to submission content and format; proficiency in the use of Adobe Professional and specialty document publishing tools; and advanced eCTD publishing experience. In addition, the candidate must posses three (3) to five (5) years of drug development/regulatory experience. Knowledge in the compliant use of an enterprise-wide EDMS and managing teams of 2 or more is preferred.
Date Posted 07/09/2009
Email Résumé to recruiting@cougarbiotechnology.com, include PR117 in the subject line.
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
