Associate Director, Regulatory Affairs, Oncology Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2345345
Location: Summit, New Jersey	Date Posted: 7/5/2008
Wage:	Category: Medical/Health
Job Code:

Job Description:
Regulatory Functional teams for the preparation of submissions, which may include INDs, Briefing Documents, Orphan Durg Drug Applications, and Marketing Applications, etc. 3. Become knowledgeable with European Regulatory laws/guidances. 4. Participate or lead Regulatory interactions with FDA .on assigned projects 5. Work with the Operations team to prepare FDA documents in electronic format. 6. Identify issues that will impact programs and work with regulatory colleagues to provide strategies for dealing with them. 7. Participate or act as regulatory representative on various cross-functional teams Skills/Knowledge Required: ? Bachelors degree in scientific discipline; Advanced scientific degree preferred; Experience in Oncology or Inflammatory Disease Drug Clinical Development preferred. ? 5-9 years pharmaceutical industry experience (to include 3-5 years in reg affairs)

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: PharmaceuticalCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.pharmaceuticalcrossing.com