OverviewIn this role you will support worldwide post-approval regulatory activities focused on CMC for vaccines or biological products. You will work within a regulatory team to shape submission strategies, assess quality-related changes, and coordinate cross-functional input for regulatory dossiers. The position emphasizes collaboration across manufacturing, QA, QC, and regulatory groups to ensure compliant submissions. You will help manage regulatory information systems and identify risks to timelines and approvals. You will contribute to Parexel's mission of improving global health by enabling efficient regulatory pathways for life-saving therapies.ResponsabilitàDevelop post-approval CMC submission strategies for variations, renewals, expansions, and annual reportsAssess change controls and regulatory implications of production and quality changesReview study reports for regulatory compliance across QC and productionCoordinate submission preparation with manufacturing, supply chain, QA,



and other regulatory teamsPrepare and review submission content aligned with regulatory requirements for variations and health authority questionsManage projects within Regulatory Information Management systems for worldwide submissionsIdentify, escalate, and mitigate regulatory risks and issuesRequisiti fondamentaliUniversity-level education in Life Sciences or equivalentExperience in regulatory affairs, especially technical/CMC/quality in pharmaStrong knowledge of CMC and post-approval regulatory requirementsExperience writing CMC sections of regulatory documents (registration files or variations)Knowledge of vaccines or biological processesBackground in validation/QA/production with regulatory documentation experienceUnderstanding of qualification/validation principlesProficiency in Word, PowerPoint, Excel; experience with Veeva Vault is valuedTeam spirit, flexibility, accountability, and organizational skillsFluent in English (written and spoken)team spiritflexibilityaccountabilityCMCpost-approval regulatory requirementsregulatory writing (CMC sections)

📌 Regulatory Affairs Consultant - Cmc Vax/Bio (Home Or Office Based) (Volpiano)
🏢 Parexel
📍 Volpiano