Director, Regulatory Affairs Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2326565
Location: Cambridge, Massachusetts	Date Posted: 6/30/2008
Wage:	Category: Medical/Health
Job Code:

Job Description:
Prepare and deliver effective presentations for external and internal audiences. · Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. · Develop and maintain highly capable and dedicated regulatory staff. Guide subordinates in carrying out responsibilities. Responsible for coordinating subordinate activities and career development. · Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position. · Provide leadership on project teams and subcommittees. · Allocate representation on relevant project teams. · Provide input to Regulatory Senior Management teams. · Foster a global view as part of the whole regulatory team. · 8 years pharmaceutical/biotechnology industry experience with technical management experience.· Minimum of 6 years in RA.· Good knowledge of applicable regulations.· Experience in interpretation of regulations, guidelines, policy statements, etc.· Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.· Experience in interfacing with relevant regulatory authorities.

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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