Regulatory Associate, CMC

at Company: Acceleron Pharma, Inc. in Job Category: Regulatory
posted on 12/30/08 12:00am

Apply Now

Company
Acceleron Pharma, Inc.

Contact Name:
Human Resources

Website:
Visit Our Website

Job Reference Code:
2008045

Position Overview:

Assist in planning, reviewing, and preparing CMC (chemistry, manufacturing and control) submissions to support clinical trials and product approvals. Provide advice on CMC strategies and provide solutions consistent with global regulations. Participate on development teams to represent the functional area. Reports to the Director (or Vice President) of Regulatory Affairs.

Job Responsibilities:
• Assist in the preparation, review and submission of CMC components of investigational new drug applications (INDs), IND amendments, and global submissions
• Assist with development of effective CMC regulatory strategies for global product development, and effectively communicate to development team
• Interact with regulatory authorities (FDA, EMEA, HPFB, etc.), as directed
• Be knowledgeable of global CMC regulatory guidance and effectively communicate any impact on Acceleron's development programs
• Ensure regulatory filings are in compliance with Acceleron's manufacturing processes bullets

Basic Qualifications:
BA/BS in biochemistry/biology or a related field, with 5 years regulatory experience. Must have a working knowledge of the drug development process in general, and CMC regulatory requirements, in particular. Must also have excellent verbal and written communication skills and experience working in a team environment.

« Back to list