CMC Post-Approval Specialist — Module 3 (EU/US), Hybrid

Eblex Group; Kalisz; Hybrid; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid workplace

12‑month contract

Job summary

Eblex Group is seeking a CMC Regulatory Affairs Specialist (Post-Approval) in Poland for a 12‑month, hybrid role. You’ll prepare and update Module 3 documentation for post‑approval changes and support variations across EU/US markets.

You will assess regulatory impact of manufacturing and quality changes and collaborate with cross‑functional teams to ensure timely submissions. The role requires hands‑on CMC experience with NDA/BLA/MAA products and a strong working knowledge of CTD formats, with

Qualifications

• Hands‑on experience in CMC regulatory affairs and post‑approval changes.
• Experience with Module 3 documentation for post‑approval changes.
• Knowledge of NDA, BLA or MAA approvals and global submissions.
• Familiarity with EU/US post‑approval requirements and CTD format.
• Fluent English in a regulatory setting.

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.
• Keep regulatory documentation accurate and up to date.

Skills

CMC regulatory affairs

Module 3

post‑approval changes

NDA/BLA/MAA experience

EU/US post‑approval requirements

CTD format

Fluent English

Job description

Eblex Group is seeking a CMC Regulatory Affairs Specialist (Post-Approval) in Poland for a 12‑month, hybrid role. You’ll prepare and update Module 3 documentation for post‑approval changes and support variations across EU/US markets.

You will assess regulatory impact of manufacturing and quality changes and collaborate with cross‑functional teams to ensure timely submissions. The role requires hands‑on CMC experience with NDA/BLA/MAA products and a strong working knowledge of CTD formats, with