Senior Regulatory Affairs – CMC Biologics
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Parexel is seeking a Senior Regulatory Affairs Associate to lead post-approval CMC activities for biologics and vaccines. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance.
This role offers remote options in several European locations and focuses on variations, renewals, and market expansions, with responsibilities spanning preparation of submissions, risk mitigation, and regulatory risk escalation.
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Senior Regulatory Affairs Associate
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Ascoli Piceno, Marche, Italia PAREXEL Tempo pienoOverview As 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,...
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Senior Regulatory Affairs Associate
1 giorno fa
ascoli piceno, Italia PAREXEL Tempo pienoOverview As 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,...
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