CMC Regulatory Affairs Specialist (Post-Approval)

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

CMC Regulatory Affairs Specialist (Post-Approval)

Workplace type: Hybrid

Location: Poland

Employment type: Contract

Duration: 12-months

Description

We’re working with a global pharmaceutical company that is building a team of CMC Regulatory Affairs Specialists to support post-approval work on its marketed products. The portfolio is mainly small molecules and traditional vaccines.

This is a hands‑on role. You’ll be preparing and updating the CMC documentation behind changes to approved products, working with the client’s regulatory team. The role isn’t agency facing and doesn’t involve regulatory strategy.

What you’ll be doing

• Preparing and updating Module 3 and Module 2.3 documentation for post‑approval changes
• Supporting variations and supplements for marketed products across the EU, US and other markets
• Assessing the regulatory impact of manufacturing and quality changes
• Supporting renewals and annual reports
• Working with manufacturing, quality and technical teams to gather and check data for submissions
• Keeping regulatory documentation accurate and up to date

What the client is looking for

• Hands‑on experience in CMC regulatory affairs, preparing or updating Module 3 documentation for post‑approval changes
• Experience with marketed products approved under a New Drug Application (NDA), Biologics License Application (BLA) or Marketing Authorisation Application (MAA)
• Experience with small molecules and/or traditional vaccines
• A good working knowledge of the CTD format and of EU and US post‑approval requirements
• Comfortable handling a steady volume of changes accurately and to deadline
• Fluent English

Good to have

• Experience of global submissions across several markets
• Experience with eCTD and regulatory systems such as Veeva Vault
• Previous contract or B2B experience

The client is hiring for several of these roles.