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Job Title: Associate Director/Director, Regulatory Affairs Operations
Description:
The Associate Director / Director, Regulatory Affairs Operations reports to the VP RAQA and has direct management responsibility for integration of clear and efficient regulatory submission processes and requirements with information technology to ensure that Cougar meets its key submission milestones. The Associate Director / Director provides leadership within Cougar RAQA and all other data generating departments for full implementation of the Common Technical Document (CTD), including eCTD, as well as develops and implements processes and requirements intended to standardize and streamline the submission process. The Associate Director / Director will be actively involved in discussions with Cougar's partners, health authorities, and professional groups (e.g., PhRMA, EFPIA) regarding standards for electronic submissions.
The Associate Director / Director is responsible for administration of MasterControls, Cougar's document management system, to ensure compliance by all contributors and compatibility with the regulatory submission publishing system, which he/she will select. The Associate Director / Director assists the VP RAQA in operational training, procedures and budgeting.
The Associate Director/Director also performs the following:
- Drives the submission process and creates and supports electronic management of health authority submissions from clinical trial application (IND, CTA) to marketing approval (NDA, MAA)
- Oversees all aspects of document management and submission publishing project management (including development of efficient processes, resolution of critical path issues, submission resource management) throughout the development cycle to marketing approval
- Contributes to the development and deployment of strategic solutions for the optimal capture, storage and workflow of all regulatory documents, contributing components and processes to ensure dossier delivery, submission publication, and product data management archives
- Analyzes trends and evaluates the impact of changes in health authority requirements for e-submissions; communicates changes to appropriate areas within Cougar Biotechnology; and implements required changes to Cougar's processes/procedures
- Identifies and implements regulatory submission processes and procedures to obtain the earliest possible regulatory approvals
- Develops and implements department-wide SOPs, policies and/or work processes to streamline all submission activities and standardize interactions with other departments
Qualifications:
- Strong knowledgeable of IT systems and document management concepts, requirements and systems
- Knowledge of FDA requirements for regulatory submissions; EU knowledge highly desirable
- Outstanding interpersonal, planning and organizational skills
- Excellent leadership and management skills
- Excellent oral and written communication skills
- 5 - 7 years of pharmaceutical industry experience
- 2 - 5 years in regulatory affairs, with demonstrated ability to interact successfully with health authorities
- Bachelor's degree in a scientific discipline is required; an advanced degree is preferred
Compensation:
Commensurate with experience
Date Posted: 11/16/2007
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 |
