Regulatory Affairs Consultant - CMC biologics (home or office based)
Parexel(21 days ago)
About this role
A Regulatory Affairs Consultant at Parexel focuses on post-approval regulatory activities for biological products, particularly related to Chemistry, Manufacturing, and Controls (CMC). The role involves developing submission strategies, assessing quality changes, reviewing study reports, and coordinating with various departments to ensure compliance with regulatory requirements.
Required Skills
- CMC
- Regulatory Submissions
- Veeva Vault
- Quality Assurance
- Validation
- Regulatory Documentation
- Manufacturing
- Biological Processes
- Regulatory Assessments
- Project Management
About Parexel
parexel.comFor over 35 years Parexel has been a trusted global CRO and biopharmaceutical services company. Learn more about how we can help.
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