Post-Approval CMC Regulatory Affairs Specialist (Hybrid)

Eblex Group; Kalisz; Hybrid; PLN 78,000 - 123,000; Part time

Job summary

Eblex Group seeks a CMC Regulatory Affairs Specialist (Post-Approval) for a 12-month contract in Poland. The role is hybrid and focuses on hands-on CMC regulatory activities behind post-approval changes to marketed products, mainly small molecules and traditional vaccines.

You will prepare and update Module 3 and Module 2.3 documentation, support variations across EU and US, assess regulatory impact of changes, and collaborate with manufacturing and quality teams to ensure accurate submissions.

Qualifications

• Hands-on experience in CMC regulatory affairs and post-approval changes.
• Experience with preparing or updating Module 3 documentation.
• Knowledge of EU/US post-approval requirements and CTD format.

Responsibilities

• Prepare and update Module 3 and Module 2.3 documentation for post-approval changes.
• Support variations and supplements for marketed products across EU, US and other markets.
• Assess regulatory impact of manufacturing and quality changes.
• Support renewals and annual reports.
• Collaborate with manufacturing, quality and technical teams to gather data for submissions.

Skills

CMC regulatory affairs

Module 3 documentation

post-approval changes

EU/US submissions

CTD format knowledge

Tools

Veeva Vault

eCTD

Job description

Eblex Group seeks a CMC Regulatory Affairs Specialist (Post-Approval) for a 12-month contract in Poland. The role is hybrid and focuses on hands-on CMC regulatory activities behind post-approval changes to marketed products, mainly small molecules and traditional vaccines.

You will prepare and update Module 3 and Module 2.3 documentation, support variations across EU and US, assess regulatory impact of changes, and collaborate with manufacturing and quality teams to ensure accurate submissions.