16 set - Lucca
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.
Responsabilità
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
Write/review submission content aligned with regulatory expectations, including health authority inquiries
Manage Regulatory Information Management systems to maintain worldwide submissions
Identify, escalate, and mitigate regulatory risks
Prepare regulatory documentation for registration files or variations (CMC/technical)
Requisiti fondamentali
University-level education, preferably Life Sciences, or equivalent by experience
Experience in regulatory affairs related to technical/CMC/quality in pharma
Strong understanding of CMC and post-approval regulatory requirements
Experience writing CMC sections of regulatory documents
Knowledge of biological or vaccine processes
Background in validation/Quality Assurance/production with regulatory documentation experience
Understanding of qualification/validation principles
Proficiency with Word, PowerPoint, Excel; experience with Veeva Vault valued
Team spirit
Flexibility
Accountability
CMC knowledge
Post-approval regulatory requirements
Regulatory submissions for variations/renewals
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