15 set - Pisa
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 variati
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