Regulatory Affairs Consultant - CMC biologics (home or office based)
ParexelJob Description
When our values align, there's no limit to what we can achieve.
Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.
As the Regulatory Affairs Consultant you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.
Primary Tasks & Responsibilities:
Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
Assess change controls and provide regulatory assessments of quality changes in production and quality control.
Review study reports from the quality control a...
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