Senior Director, Regulatory Affairs job North Chicago Illinois
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Senior Director, Regulatory Affairs Job
Employer Name: PharmaceuticalCrossing
SpiderID: 2397996
Location: North Chicago, Illinois
Date Posted: 7/26/2008
Wage:
Category: Medical/Health
Job Code: 6830962
Job Description:
Responsible for handling complex issues and providing leadership where appropriate to assigned development teams. -Act as global regulatory lead (GRL) on defined products for the Immunology therapeutic areas as well as other TAs. -Candidate will be responsible to define and implement a wide range of global pharmaceutical regulatory strategies of new medicinal products from IND phases to registration and marketing phases. -Responsible for interaction with FDA, European Agencies as appropriate, and Abbott affiliate regulatory departments around the world. -Effectively use negotiation skills to resolve complex regulatory issues in cross-functional teams to ensure meeting development objectives. -Ability to effectively negotiate basic regulatory agreements with Global Health Agencies. -Responsible to manage and coordinate regulatory responses to agency inquiries and maintain a high level of understanding of global regulatory requirements to ensure high quality responses are provided. -Candidate will also be responsible for participating in the planning and conduct for Health Agency meetings.
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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
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