Regulatory Affairs Consultant - CMC biologics (home or office based)
P
Parexel
📍 Poland, Poland, Poland
Job Description
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 and production departments to ensure compliance with regulatory req...
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 and production departments to ensure compliance with regulatory req...