Remote CMC Regulatory Lead – Biologics & Vaccines

Parexel; Napoli; À distance; EUR 70 000 - 95 000; Plein temps

Résumé du poste

Parexel is seeking a Senior Regulatory Affairs Associate to drive post-approval CMC activities for biologics and vaccines, with remote options across Europe. You will collaborate with manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance across variations, renewals, and market expansions.

The role emphasizes risk mitigation, timely regulatory assessments, and strong writing of CMC regulatory documents, while leveraging tools like Veeva Vault

Qualifications

• Post-approval regulatory experience in pharma/biologics.
• Experience with CMC and regulatory submissions.
• Strong writing and regulatory documentation skills.
• Knowledge of vaccines processes.

Responsabilités

• Develop post-approval CMC submission strategies for variations, renewals, market expansions, and annual reports.
• Assess regulatory impact of 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, elevate, and mitigate regulatory risks.
• Prepare regulatory documentation for registration files or variations (CMC/technical).

Connaissances

Regulatory expertise

Cross-functional collaboration

Attention to detail

Problem solving

Communication

Formation

Life Sciences degree or equivalent by experience

Outils

Veeva Vault

MS Office

Description du poste

Parexel is seeking a Senior Regulatory Affairs Associate to drive post-approval CMC activities for biologics and vaccines, with remote options across Europe. You will collaborate with manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance across variations, renewals, and market expansions.

The role emphasizes risk mitigation, timely regulatory assessments, and strong writing of CMC regulatory documents, while leveraging tools like Veeva Vault