Remote CMC Regulatory Lead – Biologics
Parexel is seeking a Senior Regulatory Affairs Associate to drive post-approval CMC activities for biologics and vaccines, with remote options across Europe. You will collaborate with manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance across variations, renewals, and market expansions.
The role emphasizes risk mitigation, timely regulatory assessments, and strong writing of CMC regulatory documents, while leveraging tools like Veeva Vault
The role emphasizes risk mitigation, timely regulatory assessments, and strong writing of CMC regulatory documents, while leveraging tools like Veeva Vault