Regulatory Affairs Consultant

2 giorni fa
Toscana, Italia Parexel Tempo pieno
pIn 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. /p ul liDevelop post-approval CMC submission strategies for variations, renewals, expansions, and annual reports /li liAssess change controls and regulatory implications of production and quality changes /li liReview study reports for regulatory compliance across QC and production /li liCoordinate submission preparation with manufacturing, supply chain, QA, and other regulatory teams /li liPrepare and review submission content aligned with regulatory requirements for variations and health authority questions /li liManage projects within Regulatory Information Management systems for worldwide submissions /li liIdentify, expand, and mitigate regulatory risks and issues /li liUniversity-level education in Life Sciences or equivalent /li liExperience in regulatory affairs, especially technical/CMC/quality in pharma /li liStrong knowledge of CMC and post-approval regulatory requirements /li liExperience writing CMC sections of regulatory documents (registration files or variations) /li liKnowledge of vaccines or biological processes /li liBackground in validation/QA/production with regulatory documentation experience /li liUnderstanding of qualification/validation principles /li liProficiency in Word, PowerPoint, Excel; experience with Veeva Vault is valued /li liTeam spirit, flexibility, accountability, and organizational skills /li liFluent in English (written and spoken) /li liteam spirit /li liflexibility /li liaccountability /li liCMC /li lipost-approval regulatory requirements /li liregulatory writing (CMC sections) /li /ul pRegulatory Affairs Consultant
- CMC vax/bio (home or office based) pistoia, toscana, it /p #J-18808-Ljbffr

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