Overview As a Senior Regulatory Affairs Associate, you will drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance. Your work supports variations, renewals, and market expansions, delivering timely regulatory assessments and risk mitigation.

This role offers remote options in several European locations and partners closely with cross-functional teams to make a patient impact. Develop post-approval CMC submission strategies for variations, renewals, market expansions,



and annual reports Assess regulatory impact of quality changes in production and QC Review study reports for regulatory compliance with requirements Coordinate submission preparation with manufacturing, supply chain, quality control, QA, and local/regulatory teams Manage Regulatory Information Management systems to maintain worldwide submissions University-level education, preferably Life Sciences, or equivalent by experience Experience in regulatory affairs related to technical/CMC/quality in pharma Experience writing CMC sections of regulatory documents Background in validation/Quality Assurance/production with regulatory documentation experience Proficiency with Word, PowerPoint, Excel;

experience with Veeva Vault valued Flexibility

📌 Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based) (Trieste)
🏢 Parexel
📍 Trieste