Regulatory Affairs Consultant - Cmc Vax/Bio (Home Or Office Based)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/88xjm1

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.
/pulliDevelop post-approval CMC submission strategies for variations, renewals, expansions, and annual reports /liliAssess change controls and regulatory implications of production and quality changes /liliReview study reports for regulatory compliance across QC and production /liliCoordinate submission preparation with manufacturing, supply chain, QA,



and other regulatory teams /liliPrepare and review submission content aligned with regulatory requirements for variations and health authority questions /liliManage projects within Regulatory Information Management systems for worldwide submissions /liliIdentify, escalation, and mitigate regulatory risks and issues /liliUniversity-level education in Life Sciences or equivalent /liliExperience in regulatory affairs, especially technical/CMC/quality in pharma /liliStrong knowledge of CMC and post-approval regulatory requirements /liliExperience writing CMC sections of regulatory documents (registration files or variations) /liliKnowledge of vaccines or biological processes /liliBackground in validation/QA/production with regulatory documentation experience /liliUnderstanding of qualification/validation principles /liliProficiency in Word, PowerPoint, Excel; experience with Veeva Vault is valued /liliTeam spirit, flexibility, accountability, and organizational skills /liliFluent in English (written and spoken) /liliteam spirit /liliflexibility /liliaccountability /liliCMC /lilipost-approval regulatory requirements /liliregulatory writing (CMC sections) /li /ulpRegulatory Affairs Consultant - CMC vax/bio (home or office based) caserta, campania, it /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/88xjm1