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Regulatory Affairs Coordinator

Company Name:
The Ascent Services Group
Regulatory Affairs Coordinator
Broomfield, CO
Contract

Responsibilities:
Prepare/submit regulatory filing documents
Monitor/track information and requirement changes
Some interaction with regulatory agencies
Using standard programs and systems, ensures accuracy and completeness of regulatory submissions, filings and filing systems
Maintain department databases and filing systems for regulatory submissions
Identifies potential issues and resolves routine problems
Prioritize work/receive general supervision and detailed instruction on new projects
Uses judgment/policies to reach solutions
Understands all company practices and interfaces with many management levels
Viewed as a technical resource internally
Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements (For example: OSHA, DEA, FDA, EMEA, ANVISA, etc.)

Requirements:
0+ years experience
Pharma exposure REQUIRED (practical or through education)
Bachelor degree REQUIRED, advanced degree a PLUS

Please email Lindsey Summers at lsummers(at)ascentsg.com or call at 303-694-5482
Ascent Pharma, A Division of The Ascent
services
Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry

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