Senior Regulatory Affairs, CMC (Biologics) – Remote EU

Parexel; Prato; Remote; EUR 70,000 - 100,000; Full time

Job summary

Parexel is seeking a Senior Regulatory Affairs Associate focused on CMC for biologics and vaccines. The role involves post-approval regulatory activities, worldwide submissions, and close collaboration with manufacturing, QA, QC, and regulatory teams to drive submission strategies and risk mitigation.

This position supports variations, renewals, and market expansions with a strong emphasis on regulatory documentation and health authority inquiries. Remote options across Europe are available.

Qualifications

• 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.

Responsibilities

• 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, escalation, and mitigate regulatory risks.
• Prepare regulatory documentation for registration files or variations (CMC/technical)

Skills

Veeva Vault

Word

PowerPoint

Excel

Team spirit

Flexibility

Accountability

CMC knowledge

Education

Life Sciences degree

Tools

Veeva Vault

Job description

Parexel is seeking a Senior Regulatory Affairs Associate focused on CMC for biologics and vaccines. The role involves post-approval regulatory activities, worldwide submissions, and close collaboration with manufacturing, QA, QC, and regulatory teams to drive submission strategies and risk mitigation.

This position supports variations, renewals, and market expansions with a strong emphasis on regulatory documentation and health authority inquiries. Remote options across Europe are available.