15 ott - Abruzzo
Parexel
ppAs 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. /pulliDevelop post-approval CMC submission strategies for variations, renewals, market expansions, and annual reports /liliAssess regulatory impact of quality changes in production and QC /liliReview study reports for regulatory compliance with requirements /liliCoordinate submission preparation with manufacturing, supply chain, quality control, QA, and local/regulatory teams /liliWrite/review submission content aligned with regulatory expectations,
including health authority inquiries /liliManage Regulatory Information Management systems to maintain worldwide submissions /liliIdentify, escalated, and mitigate regulatory risks /liliPrepare regulatory documentation for registration files or variations (CMC/technical) /liliUniversity-level education, preferably Life Sciences, or equivalent by experience /liliExperience in regulatory affairs related to technical/CMC/quality in pharma /liliStrong understanding of CMC and post-approval regulatory requirements /liliExperience writing CMC sections of regulatory documents /liliKnowledge of biological or vaccine processes /liliBackground in validation/Quality Assurance/production with regulatory documentation experience /liliUnderstanding of qualification/validation principles /liliProficiency with Word, PowerPoint, Excel; experience with Veeva Vault valued /liliTeam spirit /liliFlexibility /liliAccountability /liliCMC knowledge /liliPost-approval regulatory requirements /liliRegulatory su
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