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Job Title: Senior Director, Regulatory Affairs
Description:
The Senior Director, Regulatory Affairs reports to the VP RAQA and provides regulatory stewardship and global regulatory strategy (U.S. and EU) for Cougar's assigned development candidate(s). The Senior Director, Regulator Affairs acts as the Global Regulatory Leader for Cougar's lead development candidate.
The Senior Director is responsible for:
- Evaluating and integrating input from both regional and functional members of the Global Regulatory Team and Product Development Team for the assigned product(s)
- Development of the strategic regulatory approach to the Global Regulatory Plan and global regulatory input to the Development Plan to achieve optimal development and life cycle management plans
- Regulatory strategy optimization to support timely registration of assigned products
- Providing regulatory risk assessment and effective regulatory mitigation plans
- Ensuring execution of regional regulatory strategies in accordance with approved global development strategy
- Leading the Global Regulatory Team to create a coherent and globally integrated regulatory strategy
- Representing the regulatory perspective as a member of the Product Development Team
- Providing input/leadership into interactions with Health Authorities (i.e. U.S. FDA, EU EMEA)
- Developing regulatory readiness (NDA, MAA), including negotiation tactics and contingency planning
The Senior Director is accountable for:
- Development of a Core Data Sheet (CDS) that is consistent with development data and commercial objectives
- Development of a Target Product Profile (TPP) with input from functional members
- Review, input, and agreement of documents intended for regulatory submission
Qualifications:
- Proven planning and tactical skills, including extensive knowledge of U.S. FDA and EU EMEA regulations and guidelines, are required to provide guidance on all regulatory matters related to the drug development process to ensure timely start of clinical trials (IND/CTA) and approval of marketing applications (NDA/MAA)
- Outstanding interpersonal, communication, and organizational skills are required as the Director/Senior Director works cross-functionally with development functions staff from Clinical R&D and Quality Assurance, as well as externally with manufacturing and preclinical
- Excellent leadership and management skills
- Excellent written and oral communication skills
- An advanced degree, preferably in a health-related science field
- 10-14 years of pharmaceutical industry experience, with 8 years of progressive experience and responsibility in regulatory affairs involving U.S. and/or EU liaison
- Demonstration of successful submissions/management of INDs/CTAs/NDAs/BLAs/MAAs
Compensation:
Commensurate with experience
Date Posted: 10/25/2007
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 |
