CMC Regulatory Affairs Consultant: Post-Approval Vaccines/Bio

Parexel; Pistoia; Remote; EUR 60,000 - 90,000; Full time

Job summary

Parexel is seeking an Regulatory Affairs Consultant - CMC for post-approval activities related to vaccines or biological products. The role collaborates across manufacturing, QA, QC, and regulatory groups to ensure compliant submissions and timely regulatory outcomes.

You will support worldwide regulatory activities, manage regulatory information systems, and identify risks to timelines and approvals in a dynamic, global team.

Qualifications

• University-level education in Life Sciences or equivalent.
• Experience in regulatory affairs, especially technical/CMC/quality in pharma.
• Fluent in English (written and spoken).
• Experience writing CMC sections of regulatory documents.
• Knowledge of vaccines or biological processes.
• Background in validation/QA/production with regulatory documentation experience.
• Proficiency in Word, PowerPoint, Excel; experience with Veeva Vault is valued.
• Team spirit, flexibility, accountability, and organizational skills.

Responsibilities

• 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, expand, and mitigate regulatory risks and issues.

Education

University-level education in Life Sciences

Tools

Microsoft Word

PowerPoint

Excel

Veeva Vault

Job description

Parexel is seeking an Regulatory Affairs Consultant - CMC for post-approval activities related to vaccines or biological products. The role collaborates across manufacturing, QA, QC, and regulatory groups to ensure compliant submissions and timely regulatory outcomes.

You will support worldwide regulatory activities, manage regulatory information systems, and identify risks to timelines and approvals in a dynamic, global team.