OverviewAs 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.ResponsabilitàDevelop post-approval CMC submission strategies for variations, renewals, market expansions, and annual reportsAssess regulatory impact of quality changes in production and QCReview study reports for regulatory compliance with requirementsCoordinate submission preparation with manufacturing, supply chain, quality control, QA, and local/regulatory teamsWrite/review submission content aligned with regulatory expectations,



including health authority inquiriesManage Regulatory Information Management systems to maintain worldwide submissionsIdentify, escalate, and mitigate regulatory risksPrepare regulatory documentation for registration files or variations (CMC/technical)Requisiti fondamentaliUniversity-level education, preferably Life Sciences, or equivalent by experienceExperience in regulatory affairs related to technical/CMC/quality in pharmaStrong understanding of CMC and post-approval regulatory requirementsExperience writing CMC sections of regulatory documentsKnowledge of biological or vaccine processesBackground in validation/Quality Assurance/production with regulatory documentation experienceUnderstanding of qualification/validation principlesProficiency with Word, PowerPoint, Excel; experience with Veeva Vault valuedTeam spiritFlexibilityAccountabilityCMC knowledgePost-approval regulatory requirementsRegulatory submissions for variations/renewals

📌 Senior Regulatory Affairs Associate - Cmc Biologics/Vaccines (Home Or Office Based) (Ponderano)
🏢 Parexel
📍 Ponderano