21 set - Emilia-Romagna
Parexel
Overview
In 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.
Responsabilità
Develop post-approval CMC submission strategies for variations, renewals, expansions, and annual reports
Assess change controls and regulatory implications of production and quality changes
Review study reports for regulatory compliance across QC and production
Coordinate submission preparation with manufacturing, supply chain, QA, and other regulatory teams
Prepare and review submission content aligned with regulatory requirements for variations and health authority questions
Manage projects within Regulatory Information Management systems for worldwide submissions
Identify, escalate, and mitigate regulatory risks and issues
Requisiti fondamentali
University-level education in Life Sciences or equivalent
Experience in regulatory affairs, especially technical/CMC/quality in pharma
Strong knowledge of CMC and post-approval regulatory requirements
Experience writing CMC sections of regulatory documents (registration files or variations)
Knowledge of vaccines or biological processes
Background in validation/QA/production with regulatory documentation experience
Understanding of qualification/validation principles
Proficiency in Word, PowerPoint, Excel; experience with Veeva Vault is valued
Team spirit, flexibility, accountability, and organizational skills
Fluent in English (written and spoken)
team spirit
flexibility
accountability
CMC
post-approval regulatory requirements
regulatory writing (CMC sections)
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