10 ott - Prato
Parexel
Overview 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, 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.
Develop post-approval CMC submission strategies for variations, renewals, market expansions, and annual reports
Assess regulatory impact of quality changes in production and QC
Review study reports for regulatory compliance with requirements
Coordinate submission preparation with manufacturing, supply chain, quality control, QA, and local/regulatory teams
Manage Regulatory Information Management systems to maintain worldwide submissions
University-level education, preferably Life Sciences, or equivalent by experience
Experience in regulatory affairs related to technical/CMC/quality in pharma
Experience writing CMC sections of regulatory documents
Background in validation/Quality Assurance/production with regulatory documentation experience
Proficiency with Word, PowerPoint, Excel; experience with Veeva Vault valued
Flexibility
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